Senior Director Design Quality
$196k - $342.7kJohnson & Johnson
Johnson & Johnson seeks a Senior Director of Design Quality to lead strategic and operational oversight of design quality across the Heart Recovery product portfolio. The role manages a Design Quality organization supporting product development, sustaining engineering, and lifecycle management while ensuring compliance with global regulations and patient safety.
Responsibilities
- Provide strategic leadership for Design Quality across the Heart Recovery product portfolio
- Lead and develop a high-performing Design Quality organization supporting product development and lifecycle management
- Establish Design Quality strategies, objectives, and key performance indicators aligned with business goals
- Ensure design control compliance with FDA Quality System Regulation, ISO 13485, EU MDR, and applicable global requirements
- Provide quality oversight and independent assessment during design reviews, phase gate reviews, and governance processes
Requirements
- Bachelor's degree in Engineering, Life Sciences, Quality, or related technical discipline
- Minimum 15 years progressive experience in the medical device industry
- Minimum 10 years leadership experience in Quality, Design Quality, or Product Development Quality
- Demonstrated experience with Class II and/or Class III medical devices through all development phases
- Expert knowledge of FDA regulations, ISO 13485, ISO 14971, IEC 62304, and EU MDR
- Experience leading large, cross-functional teams in matrix environments
- Cardiovascular or heart failure device experience strongly preferred
Vacancy posted 8 days ago
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