Quality Engineer

Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies. Penumbra designs, develops, manufactures and markets innovative devices and has a broad portfolio of products that addresses challenging medical conditions and significant clinical needs across two major markets, neuro and peripheral vascular. Penumbra sells its products to hospitals primarily through its direct sales organization in the United States, most of Europe, Canada and Australia, and through distributors in select international markets. The Penumbra P logo is a trademark of Penumbra, Inc. Members of the Penumbra team agree that this is where their work has meaning -- we are transforming the treatment of some of the world's most devastating conditions. Penumbra is where everyone's ideas matter, and where learning and growth are constant.

As a Senior Supplier Quality Engineer at Penumbra, you will lead efforts in ensuring a robust and compliant supply chain in order to ensure the highest level of quality in new and existing products, and their compliance to applicable regulations and standards. You will work closely with cross-functional teams to resolve supplier quality issues and implement improvements to supplier performance, quality, capacity, and cost. You will be looked to drive resolution of quality issues, and lead strategic initiatives such as supplier qualifications and risk mitigation efforts.

Specific Duties and Responsibilities include providing technical and quality support for IQC, leading supplier qualifications and changes, participating in project teams, driving closure of corrective actions, aligning inspection/testing programs, investigating failures, partnering with suppliers for process improvements, leading qualification and development of suppliers, designing experiments, managing the approved supplier list, mentoring junior engineers, developing supplier performance metrics, and leading continuous improvement efforts.

Starting Base Salary: $119,000 to $166,000 annually.

Qualifications include a bachelor’s degree in engineering or scientific discipline, 5+ years of engineering experience (preferably in medical devices), and demonstrated experience in supplier quality or related technical roles. Additional qualifications include knowledge of QSR, ISO, supplier audits, ASQ CQE certification, experience with electronics and PCBAs, strong project management, communication skills, and a collaborative mindset.

Working conditions involve office, laboratory, and cleanroom environments, with on-site work and potential travel (0-25%), lifting up to 25 pounds, exposure to blood-borne pathogens, and the ability to move within the facility and communicate effectively.

What We Offer includes a collaborative environment, opportunities to work on innovative treatments, and a comprehensive benefits package with medical, dental, vision, life, AD&D, disability insurance, 401(k) with match, stock purchase plan, paid parental leave, holidays, vacation, sick leave, and more.

Penumbra, Inc. is a global healthcare company based in Alameda, California, focused on innovative therapies for challenging medical conditions. The company sells products directly and through distributors worldwide. Qualified applicants will receive equal employment consideration regardless of protected characteristics.

Lead efforts to ensure a compliant and high-quality supply chain for medical devices at Penumbra.

Senior Supplier Quality Engineer

As a Senior Supplier Quality Engineer at Penumbra, you will lead efforts in ensuring a robust and compliant supply chain in order to ensure the highest level of quality in new and existing products, and their compliance to applicable regulations and standards. You will work closely with cross-functional teams to resolve supplier quality issues and implement improvements to supplier performance, quality, capacity, and cost. You will be looked to drive resolution of quality issues, and lead strategic initiatives such as supplier qualifications and risk mitigation efforts.

Specific Duties and Responsibilities include providing technical and quality support for IQC, leading supplier qualifications and changes, participating in project teams, driving closure of corrective actions, aligning inspection/testing programs, investigating failures, partnering with suppliers for process improvements, leading qualification and development of suppliers, designing experiments, managing the approved supplier list, mentoring junior engineers, developing supplier performance metrics, and leading continuous improvement efforts.

Starting Base Salary: $119,000 to $166,000 annually.

Qualifications include a bachelor’s degree in engineering or scientific discipline, 5+ years of engineering experience (preferably in medical devices), and demonstrated experience in supplier quality or related technical roles. Additional qualifications include knowledge of QSR, ISO, supplier audits, ASQ CQE certification, experience with electronics and PCBAs, strong project management, communication skills, and a collaborative mindset.

Working conditions involve office, laboratory, and cleanroom environments, with on-site work and potential travel (0-25%), lifting up to 25 pounds, exposure to blood-borne pathogens, and the ability to move within the facility and communicate effectively.

What We Offer includes a collaborative environment, opportunities to work on innovative treatments, and a comprehensive benefits package with medical, dental, vision, life, AD&D, disability insurance, 401(k) with match, stock purchase plan, paid parental leave, holidays, vacation, sick leave, and more.

Penumbra, Inc. is a global healthcare company based in Alameda, California, focused on innovative therapies for challenging medical conditions. The company sells products directly and through distributors worldwide. Qualified applicants will receive equal employment consideration regardless of protected characteristics.Requirements:<ul><li> Bachelor’s degree in engineering or scientific discipline</li><li> 5+ years of engineering experience, preferably in a medical device environment</li><li> Demonstrated experience in Supplier Quality Engineering, Supplier Engineering, Manufacturing or Quality Engineering, R&D, or related technical roles</li><li> In depth knowledge of QSR, ISO, and applicable regulations and standards</li><li> Training and experience in performing supplier audits (a plus)</li><li> ASQ CQE certification (a plus)</li><li> Experience with Electronics and PCBAs (a plus)</li><li> Strong project management skills</li><li> Excellent communication skills</li><li> Ability to lead with humility and collaborate effectively</li><li> Versatility and flexibility to adapt to changing priorities</li></ul>Benefits:<ul><li> Medical insurance</li><li> Dental insurance</li><li> Vision insurance</li><li> Life insurance</li><li> AD&D insurance</li><li> Short and long-term disability insurance</li><li> 401(k) with employer match</li><li> Employee stock purchase plan</li><li> Paid parental leave</li><li> Eleven paid company holidays per year</li><li> Minimum of fifteen days of accrued vacation per year, increasing with tenure</li><li> Paid sick time in accordance with law</li></ul>

Penumbra

Senior Supplier Quality Engineer Lead efforts to ensure a compliant and high-quality supply chain for medical devices at Penumbra. As a Senior Supplier Quality Engineer at Penumbra, you will lead efforts in ensuring a robust and compliant supply chain in order to ensure the highest level of quality in new and existing products, and their compliance to applicable regulations and standards. You will work closely with cross-functional teams to resolve supplier quality issues and implement improvements to supplier performance, quality, capacity, and cost. You will be looked to drive resolution of quality issues, and lead strategic initiatives such as supplier qualifications and risk mitigation efforts.

Specific Duties and Responsibilities include providing technical and quality support for IQC, leading supplier qualifications and changes, participating in project teams, driving closure of corrective actions, aligning inspection/testing programs, investigating failures, partnering with suppliers for process improvements, leading qualification and development of suppliers, designing experiments, managing the approved supplier list, mentoring junior engineers, developing supplier performance metrics, and leading continuous improvement efforts.

Starting Base Salary: $119,000 to $166,000 annually.

Qualifications include a bachelor’s degree in engineering or scientific discipline, 5+ years of engineering experience (preferably in medical devices), and demonstrated experience in supplier quality or related technical roles. Additional qualifications include knowledge of QSR, ISO, supplier audits, ASQ CQE certification, experience with electronics and PCBAs, strong project management, communication skills, and a collaborative mindset.

Working conditions involve office, laboratory, and cleanroom environments, with on-site work and potential travel (0-25%), lifting up to 25 pounds, exposure to blood-borne pathogens, and the ability to move within the facility and communicate effectively.

What We Offer includes a collaborative environment, opportunities to work on innovative treatments, and a comprehensive benefits package with medical, dental, vision, life, AD&D, disability insurance, 401(k) with match, stock purchase plan, paid parental leave, holidays, vacation, sick leave, and more.

Penumbra, Inc. is a global healthcare company based in Alameda, California, focused on innovative therapies for challenging medical conditions. The company sells products directly and through distributors worldwide. Qualified applicants will receive equal employment consideration regardless of protected characteristics. Quality Engineer Engineer Penumbra medical-devices biotechnology developer-platform health health-care hospital life-sciences medical medical-device medical-equipment-manufacturing healthcare medical equipment Alameda California

As a Senior Supplier Quality Engineer, you will oversee supplier quality, lead improvement initiatives, and ensure regulatory compliance. You will collaborate with cross-functional teams to resolve quality issues and drive supplier development.

Lead Supplier Quality Engineer

Halteres Associates, LLC, provides strategic and tactical consulting services to bioscience organizations in the areas of diagnostics, therapeutics, medical devices, and life science research. We assist these organizations in the following areas:Technology and product mapping in the context of the competition's pros and consOpportunity analyses based on commercial attractiveness and the technical likelihood of success criteriaHealth economic analyses and reimbursement strategiesClinical study plans including sample banks for diagnostic studiesBusiness modeling and financial analysis

Halter is searching for a Lead Supply Quality Engineer to take responsibility for ensuring that every component in our supply chain is delivered at quality and on time. If you are an expert in implementing and managing quality systems to catch issues early, resolve them quickly, and ensure high-quality components are always delivered on-time at our Contract Manufacturers, we want to talk to you! Our Hardware manufacturing is accelerating quickly to satisfy our growing global markets and it is vital that every component that is shipped to our contract manufacturers in Asia is ready for the tough environment it will face on farm, once it is assembled into Halter hardware. Your day could include implementing statistical process control methods, running rapid analysis after failures, updating quality control documentation, and auditing supplier compliance. You should have 5+ years of experience in quality management for high-volume manufacturing, preferably electromechanical products, with proven ability to respond rapidly to quality issues, and experience working with suppliers. Proficiency in English and Mandarin is preferred, along with relevant certifications such as ASQ CQE or CQA. Willingness to travel regularly around APAC (25%+). You will thrive in a close team environment and in a fast-growing company committed to meaningful innovation. About Halter: We enable farmers to run sustainable operations, revolutionizing grazing with high-impact technology. Our team is backed by Tier 1 investors including Bessemer Venture Partners, DCVC, Blackbird, Promus Ventures, and others. Join us to solve challenging problems and make a real impact.

Halter is seeking a Lead Supplier Quality Engineer to ensure high-quality components are delivered on time from the supply chain.

China

Halter is searching for a Lead Supply Quality Engineer to take responsibility for ensuring that every component in our supply chain is delivered at quality and on time. If you are an expert in implementing and managing quality systems to catch issues early, resolve them quickly, and ensure high-quality components are always delivered on-time at our Contract Manufacturers, we want to talk to you! Our Hardware manufacturing is accelerating quickly to satisfy our growing global markets and it is vital that every component that is shipped to our contract manufacturers in Asia is ready for the tough environment it will face on farm, once it is assembled into Halter hardware. Your day could include implementing statistical process control methods, running rapid analysis after failures, updating quality control documentation, and auditing supplier compliance. You should have 5+ years of experience in quality management for high-volume manufacturing, preferably electromechanical products, with proven ability to respond rapidly to quality issues, and experience working with suppliers. Proficiency in English and Mandarin is preferred, along with relevant certifications such as ASQ CQE or CQA. Willingness to travel regularly around APAC (25%+). You will thrive in a close team environment and in a fast-growing company committed to meaningful innovation. About Halter: We enable farmers to run sustainable operations, revolutionizing grazing with high-impact technology. Our team is backed by Tier 1 investors including Bessemer Venture Partners, DCVC, Blackbird, Promus Ventures, and others. Join us to solve challenging problems and make a real impact.Requirements:<ul><li> 5+ years of experience in quality management for high-volume manufacturing, preferably electromechanical products</li><li> Committed to personal development and staying current with industry standards, methods, and trends</li><li> Proven experience in responding to and resolving quality issues rapidly to minimize production disruption</li><li> First principles thinking and ability to focus on key issues during audits or problem reviews</li><li> Experience working with suppliers to achieve outcomes based on context</li><li> High proficiency in English and Mandarin (preferred)</li><li> Relevant quality-related qualifications such as ASQ certification (e.g., CQE or CQA) are beneficial, as is formal Internal Auditor Certification</li><li> Willing to travel regularly around APAC (25%+)</li><li> Ability to work well in a close team and in a demanding, fast-scaling environment</li><li> A commitment to personal development and staying current with relevant industry standards, methods, and trends</li></ul>Benefits:<ul><li> Opportunities for personal development and industry standard certifications</li><li> Travel opportunities within APAC region</li><li> Work in a mission-driven company focused on meaningful innovation</li><li> Join a diverse, inclusive team committed to high performance</li></ul>

Halteres Associates

Lead Supplier Quality Engineer Halter is seeking a Lead Supplier Quality Engineer to ensure high-quality components are delivered on time from the supply chain. Halter is searching for a Lead Supply Quality Engineer to take responsibility for ensuring that every component in our supply chain is delivered at quality and on time. If you are an expert in implementing and managing quality systems to catch issues early, resolve them quickly, and ensure high-quality components are always delivered on-time at our Contract Manufacturers, we want to talk to you! Our Hardware manufacturing is accelerating quickly to satisfy our growing global markets and it is vital that every component that is shipped to our contract manufacturers in Asia is ready for the tough environment it will face on farm, once it is assembled into Halter hardware. Your day could include implementing statistical process control methods, running rapid analysis after failures, updating quality control documentation, and auditing supplier compliance. You should have 5+ years of experience in quality management for high-volume manufacturing, preferably electromechanical products, with proven ability to respond rapidly to quality issues, and experience working with suppliers. Proficiency in English and Mandarin is preferred, along with relevant certifications such as ASQ CQE or CQA. Willingness to travel regularly around APAC (25%+). You will thrive in a close team environment and in a fast-growing company committed to meaningful innovation. About Halter: We enable farmers to run sustainable operations, revolutionizing grazing with high-impact technology. Our team is backed by Tier 1 investors including Bessemer Venture Partners, DCVC, Blackbird, Promus Ventures, and others. Join us to solve challenging problems and make a real impact. Lead Supplier Quality Engineer Engineer Halteres Associates biotechnology biotechnology-research Guangdong

This role involves implementing quality systems, analyzing failures, and auditing suppliers to maintain quality standards. The candidate will work closely with design engineers and suppliers, primarily in the APAC region.

Senior Quality Engineer

As a Senior Quality Engineer at Penumbra, you will participate in all aspects of process development, supplier development and manufacturing in order to ensure the highest level of quality in new and existing products, and their compliance to applicable regulations and standards. You will apply your passion for detailed analysis to identify problems and determine the appropriate course of action. You will be looked to for communicating quality objectives and building a culture of quality throughout the company.

What You’ll Work On:
•Represent Quality Engineering on cross-functional teams - interfacing among multiple departments and teams such as Manufacturing, QC, R&D, Regulatory Affairs, Operations/Planning, and Marketing.
•Evaluate, analyze, and continuously improve manufacturing processes, quality controls, and engineering systems for assigned product lines.
•Own or review Engineering Change Orders on assigned projects and product lines.
•Plan, design, and implement test/inspection methods, including test/inspection equipment, to achieve product quality control objectives.
•Partner with suppliers to continually improve technical processes, reliability, and quality controls to meet Penumbra's quality standards.
•Take the lead on risk analysis and documentation.
•Lead or participate in project teams - coordinating the quality efforts to meet project objectives.
•Plan, schedule, and execute engineering project work to meet business and quality objectives.
•Provide leadership and guidance to ensure assigned projects and product lines are compliant with the quality system and regulations.
•Lead nonconforming report investigations and recommend appropriate corrective actions.
•Identify the need for Corrective Action Preventative Action (CAPA). Initiate, implement, and close CAPAs.
•Design experiments and tests, and apply statistical rationale to analyze, and interpret engineering test data.
•Provide leadership and mentoring to more junior staff. May supervise junior engineers.

Position Qualifications:
•Bachelor’s degree in Engineering, a Life Science or related field with 5+ years or relevant experience, including experience in Quality Assurance and ISO, or an equivalent combination of education and experience.
•Advanced degree preferred.
•Experience in auditing, design review, sterilization, project management, and/or product development is highly desired.

What You'll Bring:
•A passion for detailed analysis and problem solving.
•A knack for solving quality control problems effectively.
•The desire to be part of a great team and to represent Quality Engineering on cross-functional technical teams.
•The ability to present issues, plans, and objectives in a clear, compelling way, both orally and in writing.
•Versatility, flexibility, and a willingness to work within changing priorities.
•Broad knowledge of applicable regulations and standards, e.g. QSR, ISO 13485.
•Solid knowledge of sterilization, biocompatibility, and transportation and shelf-life standards.
•Working knowledge of data collection, data analysis, and evaluation, and scientific methods.
•R&D or new product development experience helpful.
•ASQ CQE preferred.

Working Conditions:
•General office, laboratory, and cleanroom environments.
•Business travel from 0% - 10%.
•Potential exposure to blood-borne pathogens.
•Requires some lifting and moving of up to 25 pounds.
•Must be able to move between buildings and floors.
•Must be able to remain stationary and use a computer or other standard office equipment, such as a printer or copy machine, for an extensive period of time each day.
•Must be able to read, prepare emails, and produce documents and spreadsheets.
•Must be able to move within the office and access file cabinets or supplies, as needed.
•Must be able to communicate and exchange accurate information with employees at all levels on a daily basis.

Location and Salary:
•Roseville, CA
•Starting Base Salary: $113,000/year - $157,000/year.
•Individual compensation will vary over time based on factors such as performance, skill level, competencies, and work location.

What We Offer:
•A collaborative teamwork environment where learning is constant, and performance is rewarded.
•The opportunity to be part of the team that is revolutionizing the treatment of some of the world's most devastating diseases.
•A generous benefits package for eligible employees that includes medical, dental, vision, life, AD&D, short and long-term disability insurance, 401(k) with employer match, an employee stock purchase plan, paid parental leave, eleven paid company holidays per year, a minimum of fifteen days of accrued vacation per year, which increases with tenure, and paid sick time in compliance with applicable law(s).

Senior Quality Engineer at Penumbra will oversee process development, supplier development, and manufacturing to ensure product quality and regulatory compliance.

As a Senior Quality Engineer at Penumbra, you will participate in all aspects of process development, supplier development and manufacturing in order to ensure the highest level of quality in new and existing products, and their compliance to applicable regulations and standards. You will apply your passion for detailed analysis to identify problems and determine the appropriate course of action. You will be looked to for communicating quality objectives and building a culture of quality throughout the company.

What You’ll Work On:
•Represent Quality Engineering on cross-functional teams - interfacing among multiple departments and teams such as Manufacturing, QC, R&D, Regulatory Affairs, Operations/Planning, and Marketing.
•Evaluate, analyze, and continuously improve manufacturing processes, quality controls, and engineering systems for assigned product lines.
•Own or review Engineering Change Orders on assigned projects and product lines.
•Plan, design, and implement test/inspection methods, including test/inspection equipment, to achieve product quality control objectives.
•Partner with suppliers to continually improve technical processes, reliability, and quality controls to meet Penumbra's quality standards.
•Take the lead on risk analysis and documentation.
•Lead or participate in project teams - coordinating the quality efforts to meet project objectives.
•Plan, schedule, and execute engineering project work to meet business and quality objectives.
•Provide leadership and guidance to ensure assigned projects and product lines are compliant with the quality system and regulations.
•Lead nonconforming report investigations and recommend appropriate corrective actions.
•Identify the need for Corrective Action Preventative Action (CAPA). Initiate, implement, and close CAPAs.
•Design experiments and tests, and apply statistical rationale to analyze, and interpret engineering test data.
•Provide leadership and mentoring to more junior staff. May supervise junior engineers.

Position Qualifications:
•Bachelor’s degree in Engineering, a Life Science or related field with 5+ years or relevant experience, including experience in Quality Assurance and ISO, or an equivalent combination of education and experience.
•Advanced degree preferred.
•Experience in auditing, design review, sterilization, project management, and/or product development is highly desired.

What You'll Bring:
•A passion for detailed analysis and problem solving.
•A knack for solving quality control problems effectively.
•The desire to be part of a great team and to represent Quality Engineering on cross-functional technical teams.
•The ability to present issues, plans, and objectives in a clear, compelling way, both orally and in writing.
•Versatility, flexibility, and a willingness to work within changing priorities.
•Broad knowledge of applicable regulations and standards, e.g. QSR, ISO 13485.
•Solid knowledge of sterilization, biocompatibility, and transportation and shelf-life standards.
•Working knowledge of data collection, data analysis, and evaluation, and scientific methods.
•R&D or new product development experience helpful.
•ASQ CQE preferred.

Working Conditions:
•General office, laboratory, and cleanroom environments.
•Business travel from 0% - 10%.
•Potential exposure to blood-borne pathogens.
•Requires some lifting and moving of up to 25 pounds.
•Must be able to move between buildings and floors.
•Must be able to remain stationary and use a computer or other standard office equipment, such as a printer or copy machine, for an extensive period of time each day.
•Must be able to read, prepare emails, and produce documents and spreadsheets.
•Must be able to move within the office and access file cabinets or supplies, as needed.
•Must be able to communicate and exchange accurate information with employees at all levels on a daily basis.

Location and Salary:
•Roseville, CA
•Starting Base Salary: $113,000/year - $157,000/year.
•Individual compensation will vary over time based on factors such as performance, skill level, competencies, and work location.

What We Offer:
•A collaborative teamwork environment where learning is constant, and performance is rewarded.
•The opportunity to be part of the team that is revolutionizing the treatment of some of the world's most devastating diseases.
•A generous benefits package for eligible employees that includes medical, dental, vision, life, AD&D, short and long-term disability insurance, 401(k) with employer match, an employee stock purchase plan, paid parental leave, eleven paid company holidays per year, a minimum of fifteen days of accrued vacation per year, which increases with tenure, and paid sick time in compliance with applicable law(s).Requirements:<ul><li> Bachelor’s degree in Engineering, a Life Science or related field with 5+ years or relevant experience, including experience in Quality Assurance and ISO, or an equivalent combination of education and experience</li><li> Experience in auditing, design review, sterilization, project management, and/or product development is highly desired</li><li> A passion for detailed analysis and problem solving</li><li> A knack for solving quality control problems effectively</li><li> The desire to be part of a great team and to represent Quality Engineering on cross-functional technical teams</li><li> The ability to present issues, plans, and objectives in a clear, compelling way, both orally and in writing</li><li> Versatility, flexibility, and a willingness to work within changing priorities</li><li> Broad knowledge of applicable regulations and standards, e.g. QSR, ISO 13485</li><li> Solid knowledge of sterilization, biocompatibility, and transportation and shelf-life standards</li><li> Working knowledge of data collection, data analysis, and evaluation, and scientific methods</li><li> R&D or new product development experience helpful</li><li> ASQ CQE preferred</li></ul>Benefits:<ul><li> A collaborative teamwork environment where learning is constant, and performance is rewarded</li><li> The opportunity to be part of the team that is revolutionizing the treatment of some of the world's most devastating diseases</li><li> A generous benefits package for eligible employees that includes medical, dental, vision, life, AD&D, short and long-term disability insurance, 401(k) with employer match, an employee stock purchase plan, paid parental leave, eleven paid company holidays per year, a minimum of fifteen days of accrued vacation per year, which increases with tenure, and paid sick time in compliance with applicable law(s)</li></ul>

Senior Quality Engineer Senior Quality Engineer at Penumbra will oversee process development, supplier development, and manufacturing to ensure product quality and regulatory compliance. As a Senior Quality Engineer at Penumbra, you will participate in all aspects of process development, supplier development and manufacturing in order to ensure the highest level of quality in new and existing products, and their compliance to applicable regulations and standards. You will apply your passion for detailed analysis to identify problems and determine the appropriate course of action. You will be looked to for communicating quality objectives and building a culture of quality throughout the company.

What You’ll Work On:
•Represent Quality Engineering on cross-functional teams - interfacing among multiple departments and teams such as Manufacturing, QC, R&D, Regulatory Affairs, Operations/Planning, and Marketing.
•Evaluate, analyze, and continuously improve manufacturing processes, quality controls, and engineering systems for assigned product lines.
•Own or review Engineering Change Orders on assigned projects and product lines.
•Plan, design, and implement test/inspection methods, including test/inspection equipment, to achieve product quality control objectives.
•Partner with suppliers to continually improve technical processes, reliability, and quality controls to meet Penumbra's quality standards.
•Take the lead on risk analysis and documentation.
•Lead or participate in project teams - coordinating the quality efforts to meet project objectives.
•Plan, schedule, and execute engineering project work to meet business and quality objectives.
•Provide leadership and guidance to ensure assigned projects and product lines are compliant with the quality system and regulations.
•Lead nonconforming report investigations and recommend appropriate corrective actions.
•Identify the need for Corrective Action Preventative Action (CAPA). Initiate, implement, and close CAPAs.
•Design experiments and tests, and apply statistical rationale to analyze, and interpret engineering test data.
•Provide leadership and mentoring to more junior staff. May supervise junior engineers.

Position Qualifications:
•Bachelor’s degree in Engineering, a Life Science or related field with 5+ years or relevant experience, including experience in Quality Assurance and ISO, or an equivalent combination of education and experience.
•Advanced degree preferred.
•Experience in auditing, design review, sterilization, project management, and/or product development is highly desired.

What You'll Bring:
•A passion for detailed analysis and problem solving.
•A knack for solving quality control problems effectively.
•The desire to be part of a great team and to represent Quality Engineering on cross-functional technical teams.
•The ability to present issues, plans, and objectives in a clear, compelling way, both orally and in writing.
•Versatility, flexibility, and a willingness to work within changing priorities.
•Broad knowledge of applicable regulations and standards, e.g. QSR, ISO 13485.
•Solid knowledge of sterilization, biocompatibility, and transportation and shelf-life standards.
•Working knowledge of data collection, data analysis, and evaluation, and scientific methods.
•R&D or new product development experience helpful.
•ASQ CQE preferred.

Working Conditions:
•General office, laboratory, and cleanroom environments.
•Business travel from 0% - 10%.
•Potential exposure to blood-borne pathogens.
•Requires some lifting and moving of up to 25 pounds.
•Must be able to move between buildings and floors.
•Must be able to remain stationary and use a computer or other standard office equipment, such as a printer or copy machine, for an extensive period of time each day.
•Must be able to read, prepare emails, and produce documents and spreadsheets.
•Must be able to move within the office and access file cabinets or supplies, as needed.
•Must be able to communicate and exchange accurate information with employees at all levels on a daily basis.

Location and Salary:
•Roseville, CA
•Starting Base Salary: $113,000/year - $157,000/year.
•Individual compensation will vary over time based on factors such as performance, skill level, competencies, and work location.

What We Offer:
•A collaborative teamwork environment where learning is constant, and performance is rewarded.
•The opportunity to be part of the team that is revolutionizing the treatment of some of the world's most devastating diseases.
•A generous benefits package for eligible employees that includes medical, dental, vision, life, AD&D, short and long-term disability insurance, 401(k) with employer match, an employee stock purchase plan, paid parental leave, eleven paid company holidays per year, a minimum of fifteen days of accrued vacation per year, which increases with tenure, and paid sick time in compliance with applicable law(s). Senior Quality Engineer Engineer Penumbra medical-devices biotechnology developer-platform health health-care hospital life-sciences medical medical-device medical-equipment-manufacturing healthcare medical equipment Roseville

This role involves evaluating manufacturing processes, leading quality initiatives, and collaborating across departments to maintain high standards. The position requires expertise in quality systems, risk analysis, and regulatory standards.

Senior Director

Gilead Sciences, Inc. is a leading biopharmaceutical company dedicated to advancing innovative medicines to prevent and treat life-threatening diseases. Founded in 1987, Gilead focuses on areas such as HIV/AIDS, liver diseases, oncology, and inflammatory and respiratory conditions. The company is committed to scientific excellence and improving patient outcomes worldwide through its extensive portfolio of antiviral drugs and therapies. Gilead operates globally, with a strong presence in research and development, manufacturing, and commercialization of its products.

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together. Job Description Senior Director, Global Supplier Quality Gilead Sciences, Inc. is a research-based biopharmaceutical company founded in 1987. Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. Our worldwide staff is a close community where you can see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through ongoing development. Our scientific focus has resulted in marketed products that are benefiting hundreds of thousands of people, a pipeline of strong late-stage drug candidates, and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them. By joining Gilead, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases. Working in PDM Global Quality at Gilead: Pharmaceutical Development & Manufacturing (PDM) Global Quality delivers on Gilead’s commitment to bring life-changing therapies to patients through robust Quality processes and systems. Our approach is agile, innovative and collaborative and our teams are committed to the successful delivery of safe life-changing therapies. Job Summary: Gilead Sciences PDM External Quality is currently seeking a leader at the Senior Director level to lead a team of 10 – 15 Quality Professionals to define, lead and manage the Global Supplier Quality program by providing quality oversight of GMP material and commodity suppliers. Being a member of the External Quality Leadership team, the successful candidate is expected to work collaboratively with internal and external networks to continually improve Gilead’s Global Supplier Quality program, from selection, onboarding, qualification, and routine quality and performance oversight of global and local GMP material and commodity suppliers. The successful candidate must have demonstrated leadership skills and extensive working knowledge of managing GMP material and commodity suppliers’ performance and relationships. The successful candidate must have exceptional skills in managing a matrix organization, consisting of Supplier Quality members from each of the internal Gilead’s sites. In addition, the successful candidate must have a technical understanding of different material categories supporting GMP manufacturing of different Gilead product modalities. It is important that the successful candidate can influence Gilead’s external network on selection of GMP material and commodity suppliers in alignment with Gilead’s standards. The successful candidate must be extremely familiar with applicable regulations and requirements with GMP material and commodity supplier management program and clarity of the role and responsibilities between marketing authorization holder and contract manufacturing organizations. The successful candidate must possess strong communication, influencing and negotiation skills, be able to evaluate options and trade-offs and utilize available resources to achieve the most positive impact to the business and be able to partner with leaders in different PDM functions including Technical Development, Packaging Development and Engineering, Global Manufacturing, Procurement, Regulatory CMC, and the Gilead Site Quality to achieve business objectives. The successful candidate must have proven track records in leading Global Supplier Quality program in other global biotech or pharmaceutical companies, preferably with established relationship with reputable GMP material and commodity suppliers. Job Functions: Execute an integrated and sustainable Global Supplier Quality strategy for Gilead’s clinical and commercial products based on the value proposition for Gilead (Integrity, Inclusion, Teamwork, Accountability, Excellence) and available SMEs. Develop processes to communicate learnings and drive any related Supplier Quality improvement initiatives to support the development of Gilead’s clinical and commercial products. Develop a process for exchange of lessons learned across multiple company representatives and identify opportunities for Gilead’s process improvements. Collaborate with Technical and Quality leadership to identify solutions and processes and align with key partners on implementation of new requirements. Implement continuous improvement initiatives to drive Global Supplier Quality program and ensure maximum productivity. Ensuring systems are world-class and meet the needs of all internal and external constituencies with an emphasis on process, quality, productivity, budget control, and profitability. Develop, implement, and monitor Global Supplier Quality program, policies, and procedures to ensure compliance with GxP standards, corporate policies, FDA, EMA, and other regulatory body regulations and guidelines. Set and drive compliance to department, site and global KPIs. Evaluate all current Global Supplier Quality systems and processes and recommend and implement appropriate enhancements and training to ensure the achievement of Gilead long-term objectives. Professional organization engagement and representation; benchmarking in industry networks. Provide guidance to the business teams on technical regulatory requirements and lead and assist where needed. Participate in different internal business and technical forums as Quality’s voice for GMP material and commodity suppliers’ oversight. Conduct regular review and assessment of regulatory intelligence and communicate any concerns, trends, gaps, alerts to Quality management in a timely fashion. Think and act globally to anticipate potential problems and risks related to regulatory compliance expectations. Approximately 20% travel is expected.

Lead and manage Gilead's Global Supplier Quality program, overseeing GMP material and commodity suppliers to ensure compliance and quality.

Senior Director, Global Supplier Quality

United States

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together. Job Description Senior Director, Global Supplier Quality Gilead Sciences, Inc. is a research-based biopharmaceutical company founded in 1987. Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. Our worldwide staff is a close community where you can see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through ongoing development. Our scientific focus has resulted in marketed products that are benefiting hundreds of thousands of people, a pipeline of strong late-stage drug candidates, and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them. By joining Gilead, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases. Working in PDM Global Quality at Gilead: Pharmaceutical Development & Manufacturing (PDM) Global Quality delivers on Gilead’s commitment to bring life-changing therapies to patients through robust Quality processes and systems. Our approach is agile, innovative and collaborative and our teams are committed to the successful delivery of safe life-changing therapies. Job Summary: Gilead Sciences PDM External Quality is currently seeking a leader at the Senior Director level to lead a team of 10 – 15 Quality Professionals to define, lead and manage the Global Supplier Quality program by providing quality oversight of GMP material and commodity suppliers. Being a member of the External Quality Leadership team, the successful candidate is expected to work collaboratively with internal and external networks to continually improve Gilead’s Global Supplier Quality program, from selection, onboarding, qualification, and routine quality and performance oversight of global and local GMP material and commodity suppliers. The successful candidate must have demonstrated leadership skills and extensive working knowledge of managing GMP material and commodity suppliers’ performance and relationships. The successful candidate must have exceptional skills in managing a matrix organization, consisting of Supplier Quality members from each of the internal Gilead’s sites. In addition, the successful candidate must have a technical understanding of different material categories supporting GMP manufacturing of different Gilead product modalities. It is important that the successful candidate can influence Gilead’s external network on selection of GMP material and commodity suppliers in alignment with Gilead’s standards. The successful candidate must be extremely familiar with applicable regulations and requirements with GMP material and commodity supplier management program and clarity of the role and responsibilities between marketing authorization holder and contract manufacturing organizations. The successful candidate must possess strong communication, influencing and negotiation skills, be able to evaluate options and trade-offs and utilize available resources to achieve the most positive impact to the business and be able to partner with leaders in different PDM functions including Technical Development, Packaging Development and Engineering, Global Manufacturing, Procurement, Regulatory CMC, and the Gilead Site Quality to achieve business objectives. The successful candidate must have proven track records in leading Global Supplier Quality program in other global biotech or pharmaceutical companies, preferably with established relationship with reputable GMP material and commodity suppliers. Job Functions: Execute an integrated and sustainable Global Supplier Quality strategy for Gilead’s clinical and commercial products based on the value proposition for Gilead (Integrity, Inclusion, Teamwork, Accountability, Excellence) and available SMEs. Develop processes to communicate learnings and drive any related Supplier Quality improvement initiatives to support the development of Gilead’s clinical and commercial products. Develop a process for exchange of lessons learned across multiple company representatives and identify opportunities for Gilead’s process improvements. Collaborate with Technical and Quality leadership to identify solutions and processes and align with key partners on implementation of new requirements. Implement continuous improvement initiatives to drive Global Supplier Quality program and ensure maximum productivity. Ensuring systems are world-class and meet the needs of all internal and external constituencies with an emphasis on process, quality, productivity, budget control, and profitability. Develop, implement, and monitor Global Supplier Quality program, policies, and procedures to ensure compliance with GxP standards, corporate policies, FDA, EMA, and other regulatory body regulations and guidelines. Set and drive compliance to department, site and global KPIs. Evaluate all current Global Supplier Quality systems and processes and recommend and implement appropriate enhancements and training to ensure the achievement of Gilead long-term objectives. Professional organization engagement and representation; benchmarking in industry networks. Provide guidance to the business teams on technical regulatory requirements and lead and assist where needed. Participate in different internal business and technical forums as Quality’s voice for GMP material and commodity suppliers’ oversight. Conduct regular review and assessment of regulatory intelligence and communicate any concerns, trends, gaps, alerts to Quality management in a timely fashion. Think and act globally to anticipate potential problems and risks related to regulatory compliance expectations. Approximately 20% travel is expected.Benefits:<ul><li> Company-sponsored medical, dental, vision, and life insurance plans.</li><li> Discretionary annual bonus.</li><li> Discretionary stock-based long-term incentives (eligibility may vary).</li><li> Paid time off.</li><li> Benefits package including health, dental, vision, and life insurance.</li></ul>

Gilead Sciences, Inc.

Senior Director, Global Supplier Quality Lead and manage Gilead's Global Supplier Quality program, overseeing GMP material and commodity suppliers to ensure compliance and quality. At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together. Job Description Senior Director, Global Supplier Quality Gilead Sciences, Inc. is a research-based biopharmaceutical company founded in 1987. Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. Our worldwide staff is a close community where you can see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through ongoing development. Our scientific focus has resulted in marketed products that are benefiting hundreds of thousands of people, a pipeline of strong late-stage drug candidates, and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them. By joining Gilead, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases. Working in PDM Global Quality at Gilead: Pharmaceutical Development & Manufacturing (PDM) Global Quality delivers on Gilead’s commitment to bring life-changing therapies to patients through robust Quality processes and systems. Our approach is agile, innovative and collaborative and our teams are committed to the successful delivery of safe life-changing therapies. Job Summary: Gilead Sciences PDM External Quality is currently seeking a leader at the Senior Director level to lead a team of 10 – 15 Quality Professionals to define, lead and manage the Global Supplier Quality program by providing quality oversight of GMP material and commodity suppliers. Being a member of the External Quality Leadership team, the successful candidate is expected to work collaboratively with internal and external networks to continually improve Gilead’s Global Supplier Quality program, from selection, onboarding, qualification, and routine quality and performance oversight of global and local GMP material and commodity suppliers. The successful candidate must have demonstrated leadership skills and extensive working knowledge of managing GMP material and commodity suppliers’ performance and relationships. The successful candidate must have exceptional skills in managing a matrix organization, consisting of Supplier Quality members from each of the internal Gilead’s sites. In addition, the successful candidate must have a technical understanding of different material categories supporting GMP manufacturing of different Gilead product modalities. It is important that the successful candidate can influence Gilead’s external network on selection of GMP material and commodity suppliers in alignment with Gilead’s standards. The successful candidate must be extremely familiar with applicable regulations and requirements with GMP material and commodity supplier management program and clarity of the role and responsibilities between marketing authorization holder and contract manufacturing organizations. The successful candidate must possess strong communication, influencing and negotiation skills, be able to evaluate options and trade-offs and utilize available resources to achieve the most positive impact to the business and be able to partner with leaders in different PDM functions including Technical Development, Packaging Development and Engineering, Global Manufacturing, Procurement, Regulatory CMC, and the Gilead Site Quality to achieve business objectives. The successful candidate must have proven track records in leading Global Supplier Quality program in other global biotech or pharmaceutical companies, preferably with established relationship with reputable GMP material and commodity suppliers. Job Functions: Execute an integrated and sustainable Global Supplier Quality strategy for Gilead’s clinical and commercial products based on the value proposition for Gilead (Integrity, Inclusion, Teamwork, Accountability, Excellence) and available SMEs. Develop processes to communicate learnings and drive any related Supplier Quality improvement initiatives to support the development of Gilead’s clinical and commercial products. Develop a process for exchange of lessons learned across multiple company representatives and identify opportunities for Gilead’s process improvements. Collaborate with Technical and Quality leadership to identify solutions and processes and align with key partners on implementation of new requirements. Implement continuous improvement initiatives to drive Global Supplier Quality program and ensure maximum productivity. Ensuring systems are world-class and meet the needs of all internal and external constituencies with an emphasis on process, quality, productivity, budget control, and profitability. Develop, implement, and monitor Global Supplier Quality program, policies, and procedures to ensure compliance with GxP standards, corporate policies, FDA, EMA, and other regulatory body regulations and guidelines. Set and drive compliance to department, site and global KPIs. Evaluate all current Global Supplier Quality systems and processes and recommend and implement appropriate enhancements and training to ensure the achievement of Gilead long-term objectives. Professional organization engagement and representation; benchmarking in industry networks. Provide guidance to the business teams on technical regulatory requirements and lead and assist where needed. Participate in different internal business and technical forums as Quality’s voice for GMP material and commodity suppliers’ oversight. Conduct regular review and assessment of regulatory intelligence and communicate any concerns, trends, gaps, alerts to Quality management in a timely fashion. Think and act globally to anticipate potential problems and risks related to regulatory compliance expectations. Approximately 20% travel is expected. Senior Director Director Gilead Sciences, Inc. Biotechnology Pharmaceuticals Healthcare Foster City

This role involves leading a team of quality professionals to develop and implement supplier quality strategies, ensuring regulatory compliance and continuous improvement. The position requires extensive experience in GMP supplier management within the biopharmaceutical industry.

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