Sr. Director Quality
Position Summary
The Senior Director, Quality will lead the company's Quality Management System (QMS) and provide strategic oversight of quality across product development, manufacturing, supplier quality, and post-market activities. This individual will ensure compliance with FDA, ISO 13485, EU MDR, and other global regulations while driving continuous improvement and operational excellence.
Key Responsibilities
- Lead and develop Quality Systems, Design Quality, Manufacturing Quality, and Supplier Quality functions.
- Maintain compliance with FDA 21 CFR Part 820/QMSR, ISO 13485, EU MDR, and MDSAP requirements.
- Provide quality leadership for product development, design controls, risk management, verification/validation, and design transfer activities.
- Oversee CAPA, nonconformance, complaint handling, root cause investigations, and quality metrics.
- Drive process validation activities (IQ/OQ/PQ) and continuous improvement initiatives.
- Lead FDA inspections, notified body audits, and customer audits.
- Partner with R&D, Operations, Regulatory Affairs, and Supply Chain to ensure product quality and business objectives are achieved.
- Develop quality strategy, KPIs, and organizational capability to support company growth.
Qualifications
- Bachelor's degree in Engineering, Life Sciences, or related technical discipline.
- 15+ years of quality experience within FDA-regulated medical device environments.
- 8+ years of leadership experience managing quality organizations.
- Expertise in Design Controls, CAPA, Risk Management (ISO 14971), Process Validation, Supplier Quality, and Quality Systems.
- Strong working knowledge of FDA regulations, ISO 13485, EU MDR, and MDSAP.
- Experience supporting Class II and/or Class III medical devices and regulatory inspections.
- ASQ certifications, advanced degree, or Lean Six Sigma certification preferred.
Preferred Background
Experience in cardiovascular, structural heart, electrophysiology, neuromodulation, implantable devices, or other complex Class III medical device technologies.
FAQs
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