Quality Engineering Manager

Overview
The Quality Engineering Manager is responsible for leading product quality and compliance initiatives across the full product lifecycle, ensuring adherence to FDA regulations, ISO standards, and internal quality systems. This role partners cross-functionally with R&D, Manufacturing, Regulatory Affairs, and Supply Chain to drive product quality, risk management, and continuous improvement.

Key Responsibilities

• Lead and develop a team of Quality Engineers supporting new product development and sustaining operations
• Drive Design Assurance activities including design controls, risk management (ISO 14971), and verification/validation (V&V)
• Ensure compliance with FDA QSR (21 CFR Part 820), ISO 13485, and global regulatory requirements
• Oversee CAPA, nonconformance (NCR), and complaint handling processes; ensure timely and effective resolution
• Partner with Manufacturing Engineering to support process validation (IQ/OQ/PQ) and ongoing process monitoring
• Support regulatory submissions (510(k), PMA) through quality deliverables and technical documentation
• Lead internal and external audits, including FDA inspections and notified body audits
• Establish and track quality metrics (e.g., yield, scrap, complaint trends) to drive continuous improvement
• Collaborate with Supplier Quality to ensure incoming material quality and supplier performance
• Serve as quality representative on cross-functional product development and change control teams

Qualifications

• Bachelor's degree in Engineering or related technical field (Mechanical, Biomedical, or similar)
• 7-10+ years of quality engineering experience in the medical device industry
• 2-4+ years of leadership or people management experience
• Strong knowledge of FDA regulations (21 CFR Part 820) and ISO 13485
• Experience with design controls, risk management (ISO 14971), and verification/validation activities
• Background supporting Class II and/or Class III medical devices
• Experience with root cause analysis tools (e.g., 8D, Fishbone, FMEA) and statistical methods
• Familiarity with manufacturing processes, process validation, and supplier quality management

Preferred Skills

• Experience supporting catheter-based, implantable, or combination products
• ASQ Certified Quality Engineer (CQE) or equivalent certification
• Exposure to international regulatory standards (EU MDR, MDSAP)
• Lean Six Sigma certification or continuous improvement experience

Key Competencies

• Strong cross-functional leadership and communication skills
• Ability to influence stakeholders and drive quality culture
• High attention to detail with risk-based decision-making mindset
• Data-driven approach to problem solving and process improvement