New · posted Nov 12
Penumbra · Medical Devices
Supplier Quality Engineering Manager – Supplier Controls
- Alameda, CA
- Hybrid
- Full-time
- Manager
The role
We are seeking a Supplier Quality Engineering Manager to help manage our Supplier Controls. This position is responsible for the effective execution, oversight, and continuous improvement of supplier quality processes and controls that support manufacturing operations and regulatory compliance.
The manager will own key supplier quality processes, including Approved Supplier List (ASL) management, supplier onboarding and qualification controls, and supplier performance monitoring. This individual will ensure that established processes are consistently executed, appropriately controlled, and compliant with quality management system requirements while driving improvements that enhance efficiency, standardization, and operational effectiveness.
The role will play an important part in modernizing supplier quality processes and systems, leveraging enterprise platforms and cross-functional partnerships to simplify workflows, strengthen controls, and improve how supplier quality activities are managed. The manager will also lead a dedicated team of Supplier Quality Engineers supporting supplier quality operations and the needs of Operational Procurement across multiple manufacturing sites.
The successful candidate will bring strong supplier quality engineering fundamentals, practical experience managing quality processes, effective people leadership, and a continuous improvement mindset.
Leadership Expectations
The Supplier Controls Manager is expected to demonstrate strong ownership of supplier quality processes, ensuring they are effectively executed, appropriately controlled, and continuously improved.
This individual should possess the technical judgment to evaluate supplier quality risks, the operational discipline to maintain reliable and compliant processes, and the initiative to improve and modernize established ways of working.
Success in this role requires balancing daily supplier quality responsibilities with process improvement, effective cross-functional collaboration, employee development, and support for manufacturing operations.
What you need
Required Qualifications
- Bachelor's degree in Engineering, Science, or a related technical discipline.
- 8+ years of progressive experience in Supplier Quality Engineering, Quality Engineering, or related quality functions within a regulated manufacturing environment.
- Strong working knowledge of supplier quality management processes, including supplier qualification, supplier onboarding and approval, supplier controls, supplier performance monitoring, supplier changes, and nonconformance management.
- Experience managing or providing technical leadership to quality engineering teams.
- Demonstrated ability to manage quality processes, ensure procedural compliance, and drive improvements in operational execution.
- Experience working with ERP and/or electronic quality management systems in support of quality processes and controls.
- Working knowledge of ISO 13485, FDA Quality Management System Regulation (QMSR), and applicable supplier control requirements.
- Strong organizational, analytical, communication, and cross-functional collaboration skills.
Preferred Qualificationsnice to have
- Supplier Quality Engineering experience in medical device manufacturing.
- Experience managing Approved Supplier Lists, supplier qualification records, supplier approval workflows, and related QMS processes.
- Experience with SAP, AssurX, TrackWise, MasterControl, or comparable enterprise and quality management systems.
- Experience improving quality workflows, defining business requirements, and supporting electronic system enhancements and implementation.
- Experience establishing or maintaining supplier performance metrics, scorecards, and quality reporting.
- Experience supporting supplier quality activities across multiple manufacturing locations.
- Demonstrated success improving quality process efficiency, standardization, and execution.
- ASQ certification, Lean Six Sigma certification, or relevant continuous improvement training.
What you'll do
Supplier Quality Controls
- Own and manage supplier quality control processes, including ASL maintenance, supplier addition requests, supplier approval status, and associated supplier qualification controls.
- Ensure supplier onboarding, approval, and qualification activities are executed consistently, efficiently, and in accordance with established risk-based requirements and quality management system procedures.
- Maintain effective governance of supplier quality records, approval workflows, supplier status, and associated documentation to ensure traceability, accuracy, and regulatory compliance.
- Establish and maintain standardized processes, clear accountability, and appropriate controls to ensure reliable execution and sustained compliance.
- Monitor process effectiveness, address execution gaps, and drive improvements in process adherence, turnaround times, and operational efficiency.
Supplier Quality Process Improvement
- Drive the improvement and modernization of supplier quality processes to enhance efficiency, simplify workflows, strengthen controls, and support evolving business needs.
- Improve the utilization and effectiveness of enterprise systems, including SAP, AssurX, TrackWise, and other applicable quality management platforms, to support supplier quality activities.
- Partner with Quality Engineering leadership, IT, Quality Systems, and cross-functional stakeholders to identify improvement opportunities, define business requirements, and implement practical, sustainable solutions.
- Support the transition of manual supplier quality activities to streamlined, electronically managed processes that maintain appropriate quality system controls and regulatory compliance.
- Coordinate process changes, system implementation activities, validation support, and associated QMS documentation updates with appropriate functional stakeholders.
- Ensure improvements are effectively implemented, adopted, and sustained through standardized practices, training, and ongoing process monitoring.
Supplier Quality Performance Monitoring
- Manage standardized processes for monitoring, tracking, and reporting supplier quality performance, including supplier nonconformances, corrective actions, supplier changes, and other established quality indicators.
- Ensure supplier quality data is accurate, consistent, and accessible to support supplier performance evaluations, trend analysis, and management decision-making.
- Collaborate with manufacturing sites to ensure consistent application of supplier quality processes, controls, and performance monitoring practices.
- Support supplier quality activities across domestic and international manufacturing locations, including supplier onboarding, supplier-related requests, receiving quality issues, and supplier changes.
- Partner with site Quality Engineering, Incoming Quality Control, and Operational Procurement teams to address process inconsistencies and improve cross-site coordination.
Team Leadership
- Lead, coach, and develop a team of Supplier Quality Engineers responsible for supplier controls and assigned operational support activities.
- Provide dedicated engineering support for Supplier Change assessments, incoming quality nonconformances, and other supplier quality activities in coordination with Supplier Quality Engineering leadership.
- Ensure timely, technically sound, and risk-based execution of assigned supplier quality activities in accordance with established procedures and quality system requirements.
- Partner closely with other SQE Managers and Operational Procurement to align priorities, balance resources, and support timely resolution of supplier quality needs.
- Establish clear team expectations, develop employee capabilities, and foster a culture of accountability, collaboration, and continuous improvement.
Pay
$145,000 – $214,000 a year
Employer providedLocation and Salary
- Location: Alameda, CA
- Annual Base Salary Range: $145,000 to $214,000
- We offer a competitive compensation package plus a benefits and equity program, when applicable. Individual total compensation will vary based on factors such as qualifications, skill level, competencies, and work location.
• 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, 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).
Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies. Penumbra designs, develops, manufactures, and markets novel products and has a broad portfolio that addresses challenging medical conditions in markets with significant unmet need. Penumbra sells its products to hospitals and healthcare providers 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 logo is a trademark of Penumbra, Inc.
Where you'll work
Alameda, CAHybridOpen in Maps (opens in a new tab)
More jobs in Alameda, CAWorking conditions
- General office, laboratory, and cleanroom environments
- Willingness and ability to work on site. May have business travel from 0% - 25%
- 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.
Equal opportunity, accessibility and legal noticesPenumbra's statements, word for word
Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, age, disability, military or veteran status, or any other characteristic protected by federal, state, or local laws.
If you reside in the State of California, please also refer to Penumbra's Privacy Notice for California Residents.
For additional information on Penumbra’s commitment to being an equal opportunity employer, please see Penumbra's AAP Policy Statement.
Job intelligence
The context around this role
Live data · November 12, 2026
Salary intelligence
How the pay compares
This role's midpoint is 18% above the US median for Supplier Quality roles at this level.
This roleEmployer provided
Manager roles in the US14 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $145,000 | — | $214,000 |
| All US (middle half) | $143,875 | $152,250 | $175,625 |
This role: Penumbra's own published range. Comparisons: the base pay employers published on open Supplier Quality roles at the same level on Regulatory Jobs, November 12, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Supplier Quality
The general path across 87 open Supplier Quality roles on Regulatory Jobs, with the titles they carry most. Not Penumbra's own promotion track.
Career resources on Supplier Quality
Skills DNA
What this role leans on
How many of the posting's 44 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Quality systems and risk34
- Collaboration and leadership14
- GMP and compliance6
- Validation and qualification6
- Documentation and SOPs5
- Investigations and CAPA3
- Data and digital systems2
- Lab testing and methods1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Supplier Quality work in medical devices, led by the two this posting names, each linked to the agency or standards body that publishes it.
- FDA21 CFR Part 820 (QMSR)(official source, opens in a new tab)FDA quality management system regulation for medical devices, aligned with ISO 13485Named in the posting
- ISOISO 13485(official source, opens in a new tab)Quality management systems for medical devicesNamed in the posting
- ISOISO 19011(official source, opens in a new tab)Guidelines for auditing management systems
- ISOISO 14971(official source, opens in a new tab)Application of risk management to medical devices
- ISOISO 14644-1(official source, opens in a new tab)Cleanroom air cleanliness classification by particle concentration
- ISOISO 2859-1(official source, opens in a new tab)Sampling procedures for inspection by attributes (AQL sampling plans)
- FDAMDSAP(official source, opens in a new tab)The Medical Device Single Audit Program shared by five regulators
- ISOISO 9001(official source, opens in a new tab)Quality management systems requirements
- EUEU MDR (Regulation 2017/745)(official source, opens in a new tab)The EU Medical Device Regulation: CE marking, technical documentation, vigilance
- ISOISO 10993-1(official source, opens in a new tab)Biological evaluation of medical devices within a risk management process
- ISOISO 11135(official source, opens in a new tab)Ethylene oxide sterilization of health care products
- ISOISO 11137-1(official source, opens in a new tab)Radiation sterilization of health care products
- ISOISO 11607-1(official source, opens in a new tab)Packaging for terminally sterilized medical devices
- ISOISO/IEC 17025(official source, opens in a new tab)Competence of testing and calibration laboratories
- FDA21 CFR Part 806(official source, opens in a new tab)Reports of medical device corrections and removals
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
Company hiring pulse
Penumbra on Regulatory Jobs
- 12
- Open roles
- 12
- Distinct roles
- 3
- Locations
By discipline
- Quality11 85%
- Clinical2 15%
By level
- Senior & Principal7 54%
- Manager4 31%
- Associate & Specialist2 15%
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Supplier Quality Engineering Manager – Supplier Controls at Penumbra
Open until filled. $145K–$214K a year, employer provided.