Senior Manager, RDQA
AbbVie · Branchburg, NJ
RoleLantern re-checked this role's application link recently and it was active — the employer has not confirmed it directly.
Role summary
Senior Manager overseeing research and development device quality at AbbVie in Branchburg, NJ. Provides direction on design control, risk management, and human factors engineering for medical devices and combination products throughout development and change control processes.
Where this listing comes from
This listing was compiled by RoleLantern from the employer's publicly available posting on SmartRecruiters, captured and rephrased by RoleLantern using automated (AI) tools on 2026-10-04 (originally posted 2026-09-17). It was not submitted or confirmed by the employer through RoleLantern. Details may be inaccurate, incomplete, outdated, or no longer available; please confirm with the employer's official posting before applying.
What they're looking for
- 10+ years medical device industry experience with 2+ years project management
- Bachelor's degree in engineering or scientific discipline; Master's preferred
- Expert knowledge of 21 CFR Part 820, ISO 13485, ICH Q9, and related regulatory standards
- Skilled in requirements analysis with testable and measurable specifications
- Proficiency in reliability analysis, FMEA, DOE, and statistical process control
- Strong verbal and written communication skills, especially technical report writing
- Experience interacting with regulatory agencies and notified bodies
What you'll be doing
- Provide quality methodology guidance and review for medical device design, development, and change control
- Participate in cross-functional design teams assessing documentation for safety, verification, validation, and manufacturability
- Lead design, manufacturability, and reliability activities including robust engineering and capability analysis
- Ensure compliance with FDA Quality System Regulation, ISO 13485, and applicable standards
- Support regulatory audits and inspections while driving quality harmonization and continuous improvement
Privacy & handoff
This role links to AbbVie's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.