Senior Quality Engineer, Medical Device External Quality
AbbVie
July 02, 2026
On-site
Pleasanton, CA
$84,500 - $162,000 USD yearly
Operations
Senior Quality Engineer, Medical Device External Quality (EPQA)
Responsibilities:
- Manage CMOs and/or third-party suppliers to ensure timely and compliant release of commercial products and/or components per defined specifications and processes.
- Oversee non-conformances, CAPAs, reworks, and deviations: ensure accurate documentation, review, and approval; resolve compliance issues for commercial products and/or custom components.
- Support Late-Stage Development and/or New Product Introduction (NPI) activities.
- Develop and maintain Supplier Quality Technical Agreements; review and approve supplier process changes impacting device/component manufacture.
- Review and approve technical protocols, reports, and specifications as appropriate.
- Contribute to global Product Quality Assurance strategy for medical devices/combination products manufactured at third-party manufacturing (TPM) facilities.
- Perform final quality release of manufactured product lots for products/product lines prepared by Third Party Manufacturers (if required).
- Interface with Global Quality Assurance audit team to build audit/due diligence/inspection readiness plans; review audit observations/responses; maintain corrective action timetables; support supplier audits during CMO site audits.
- Lead quality reviews with assigned Third Party Manufacturers; develop/maintain supplier KPIs and trend analysis (as applicable).
Qualifications:
- Bachelor’s degree in engineering (mechanical, industrial, chemical, electrical) or other technical discipline, or advanced degree; or equivalent experience; at least 7 years in a regulated medical device industry.
- Minimum 6 years quality engineering experience in FDA-regulated medical device manufacturing environments.
- Proficiency reading/interpreting mechanical drawings and GD&T.
- Knowledge of QSR and ISO 13485.
- Medical Device Auditor certification preferred.
Responsibilities:
- Manage CMOs and/or third-party suppliers to ensure timely and compliant release of commercial products and/or components per defined specifications and processes.
- Oversee non-conformances, CAPAs, reworks, and deviations: ensure accurate documentation, review, and approval; resolve compliance issues for commercial products and/or custom components.
- Support Late-Stage Development and/or New Product Introduction (NPI) activities.
- Develop and maintain Supplier Quality Technical Agreements; review and approve supplier process changes impacting device/component manufacture.
- Review and approve technical protocols, reports, and specifications as appropriate.
- Contribute to global Product Quality Assurance strategy for medical devices/combination products manufactured at third-party manufacturing (TPM) facilities.
- Perform final quality release of manufactured product lots for products/product lines prepared by Third Party Manufacturers (if required).
- Interface with Global Quality Assurance audit team to build audit/due diligence/inspection readiness plans; review audit observations/responses; maintain corrective action timetables; support supplier audits during CMO site audits.
- Lead quality reviews with assigned Third Party Manufacturers; develop/maintain supplier KPIs and trend analysis (as applicable).
Qualifications:
- Bachelor’s degree in engineering (mechanical, industrial, chemical, electrical) or other technical discipline, or advanced degree; or equivalent experience; at least 7 years in a regulated medical device industry.
- Minimum 6 years quality engineering experience in FDA-regulated medical device manufacturing environments.
- Proficiency reading/interpreting mechanical drawings and GD&T.
- Knowledge of QSR and ISO 13485.
- Medical Device Auditor certification preferred.