Senior Manager, RDQA

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.

Responsibilities

• 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

Requirements

• 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