Senior Director of Quality
Role: Sr. Director of Quality
Location: Minneapolis, MN (On-site)
Salary: $185k - $250k
EPM is partnering with an innovative cardiovascular medical device company developing next-generation technologies designed to improve patient outcomes in structural heart, cardiac rhythm management, and interventional cardiology. As the organization continues to grow, they are seeking a Director of Quality to lead and scale the Quality function across product development, manufacturing, and post-market activities.
Responsibilities
- Lead and maintain the Quality Management System (QMS) in compliance with FDA, ISO 13485, and global regulatory requirements.
- Partner closely with cross-functional teams including R&D, Regulatory Affairs, Clinical, Operations, Manufacturing, and Supply Chain.
- Drive Design Assurance activities throughout the product lifecycle, including Design Controls, risk management, verification, validation, and design transfer.
- Oversee CAPA, complaint investigations, nonconformance management, internal audits, supplier quality, and post-market surveillance.
- Lead regulatory inspections, notified body audits, and customer audits.
Qualifications
- Bachelor's degree in Engineering, Life Sciences, or a related technical discipline.
- 10+ years of Quality experience within the medical device industry.
- Prior leadership experience managing Quality teams and cross-functional initiatives.
- Strong knowledge of FDA Quality System Regulations, ISO 13485, Design Controls, CAPA, risk management, and product lifecycle quality.
- Experience supporting Class II and/or Class III medical devices.
- Experience within cardiovascular, structural heart, electrophysiology, cardiac rhythm management, vascular intervention, or other implantable medical devices strongly preferred.
Why This Opportunity?
- Play a key role in supporting innovative Class III and implantable medical devices through critical stages of growth and commercialization.
- Influence Quality strategy at both the operational and executive levels.
- Partner directly with senior leadership to help shape the future of the organization.
- Competitive compensation, bonus, equity, and comprehensive benefits package.
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