Senior Quality Engineer, Medical Device External Quality
About The Position
The Senior Quality Engineer, Medical Device External Quality is part of AbbVie’s External and Product Quality Assurance group and reports to the Senior Manager, Medical Device External Quality. The role will be based out of Lake County, IL site or Pleasanton, CA. This role primarily oversees external product quality assurance (EPQA) for commercial medical devices which are manufactured by third parties (TPM). In this capacity, the Manager, Medical Device External Quality, champions best practices related to sustaining supplier qualifications, product quality, equipment qualification, and manufacturing process validations. As such, the Manager, Medical Device External Quality, works closely with AbbVie’s Contract Manufacturing Organizations (CMOs), relevant third-party suppliers (e.g., custom components and finished devices), and internal stakeholders to ensure compliance with defined specifications and regulatory requirements.
Requirements
- Bachelor’s degree in engineering (mechanical, industrial, chemical, electrical), or other technical discipline, or advanced degree in other disciplines, or equivalent experience preferred with at least 7 years in a regulated medical device industry.
- Minimum of 6 years of quality engineering experience in FDA regulated medical device manufacturing environment(s).
- Proficiency in reading and interpreting mechanical drawings and GD&T.
- Knowledge of QSR and ISO 13485.
Nice To Haves
- Medical Device Auditor certification preferred.
Responsibilities
- Manages CMOs and/or third-party suppliers to assure timely and compliant release of commercial products and/or components in accordance with defined specifications and processes.
- Oversee CMOs and/or third-party suppliers to ensure that non-conformances, CAPAs, Reworks, and deviations are accurately documented, reviewed, and approved as well as resolving compliance issues related to commercial product and/or custom components
- Supports Late-Stage Development and/or New Product Introduction (NPI) activities
- Develops and maintains supplier Quality Technical Agreement. Review and approve changes to supplier processes which impact device and/or component manufacture.
- Review and approve technical protocols, reports, and specifications, as appropriate.
- Participates in the development of global Product Quality Assurance strategy to support medical devices and/or combination products produced at third party manufacturing (TPM) facilities.
- Performs final quality release of manufactured product lots for products and/or product lines prepared by Third Party Manufacturers if required.
- Interfaces with Global Quality Assurance audit team to develop audit plans, due diligence plans, and inspection readiness plans, review audit observations and responses, and maintain corrective action timetable. Support Supplier Audit function during CMO site audits.
- Leads quality reviews with assigned Third Party Manufacturers that identify and address quality, operational, and organizational issues. Champions development and maintenance of KPIs and trend analysis at supplier site, as applicable
Benefits
- paid time off (vacation, holidays, sick)
- medical/dental/vision insurance
- 401(k)
- short-term incentive programs
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What This Job Offers
Job Type
Full-time
Career Level
Senior
