We are open to the Principal Quality Engineer working remote or hybrid approach, however based out of Southern California.
The Principal QE is part of AbbVie’s Third-Party Device Quality group, based in Irvine, CA, and reports to the Director, Medical Device Quality (or equivalent).
The role oversees product quality assurance (PQA) for commercial medical devices which are manufactured by third parties. As such, the Principal QE works closely with AbbVie’s Contract Manufacturing Organizations (CMOs), relevant third-party suppliers (e.g., custom components), and internal stakeholders to ensure compliance with defined specifications and regulatory requirements.
The position supports Quality Management System activities, including – but not limited to – routine product release, CAPAs/NCRs, Change Control, Complaints, Product Release, Supplier Quality Agreements, etc.
The Principal QE provides strong technical leadership in the TPQ Quality function amongst peers, ensuring that functional activities are compliant and aligned with overall company goals and strategies.
Duties & Responsibilities
- Work with CMOs and/or third-party suppliers to assure timely and compliant release of commercial product and/or components in accordance with defined specifications and processes
- Work with CMOs and/or third-party suppliers to ensure that non-conformances, CAPAs, Reworks, and deviations are accurately documented, reviewed, and approved
- Work with CMOs and/or third-party suppliers to resolve compliance issues related to commercial product and/or custom components
- Review and approve changes to supplier processes which impact device and/or component manufacture
- Review and approve technical protocols, reports, and specifications, as appropriate
- Support the development of and updates to third party device Risk Management Files
- Champion development and maintenance of KPIs and trend analysis at supplier site, as applicable
- Escalate issues to Quality leadership, as appropriate
- Support Device Analysis Lab activities, including evaluation of returned devices and DHR review, as appropriate
- Support Quality Systems group during Regulatory inspections (i.e., serve as product SME)
- Support Supplier Audit function during CMO site audits
- Develop and maintain effective cross-functional relationships
- Degree in engineering, physical, or life sciences with direct experience working in a regulated environment:
- Bachelor's Degree: 10 years’ experience
- Master’s Degree: 7 years’ experience
- Doctoral Degree: 3 years’ experience
- Experience working with medical device suppliers
- Working knowledge of medical device regulations (e.g., 21 CFR 820, ISO 13485, EU MDR 2017/745, etc.)
- Working knowledge of Statistical Process Controls (SPCs)
- Working knowledge of Acceptance Sampling (AQL, RQL) and related tools (e.g., ANSI/ASQ Z1.4, Z1.9, etc.)
- Basic understanding of Design-of-Experiments (DOE)
- Experience in cGMPs
- Experience reviewing and approving production drawings, batch history records/DHRs, and other documentation
- Experience working with equipment qualifications or process validations
- The ability to recognize problems and take corrective measures
- Strong attention to detail
- Organized, with strong multitasking abilities
- Ability to work collaboratively and independently
- Fluent in verbal and written English
- ASQ Certification (CQA, CQE, CRE) or international equivalent
- Six-sigma certification
- Working knowledge of design control requirements (21 CFR 820.30)
Physical Job Requirements
- This position primarily works in an office environment (85%), however it may also include time in a laboratory and/or at an external plant – both which may require standing and manual labor. Travel time is less than 20%.
When submitting your resume, please include a writing sample which describes how you’ve used Quality tools to solve a problem, and/or describes your approach to continuous improvement (2-4 paragraphs).
Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel: Yes, 5 % of the Time
Job Type: Experienced