Senior Director of Quality

EPM Scientific; Minneapolis (MN); On-site; USD 185,000 - 250,000; Full time

Job summary

EPM Scientific invites applications for Sr. Director of Quality with a strong medical device quality systems background.

This on-site Minneapolis, MN role leads QMS, Design Controls, CAPA, and post-market activities across development, manufacturing, and services. You will partner with R&D, Regulatory, Clinical, Operations, and Supply Chain to scale quality processes and prepare for FDA inspections and regulatory audits.

Qualifications

• 10+ years of quality experience in medical devices.
• Leadership experience managing quality teams and cross-functional initiatives.
• Strong knowledge of FDA QSR, ISO 13485, Design Controls, CAPA, risk management, and product lifecycle quality.
• Experience with Class II and/or Class III medical devices.
• Experience in cardiovascular/implantable devices is a plus.

Responsibilities

• Lead and maintain the Quality Management System (QMS) in compliance with FDA, ISO 13485, and global regulatory requirements.
• Partner with R&D, Regulatory Affairs, Clinical, Operations, Manufacturing, and Supply Chain.
• Drive design assurance activities across the lifecycle, including Design Controls, risk management, verification, validation, and design transfer.
• Oversee CAPA, investigations, nonconformances, internal audits, supplier quality, and post-market surveillance.
• Lead regulatory inspections, notified body audits, and customer audits.

Skills

Leadership

Cross-functional collaboration

Regulatory knowledge

Quality systems

Problem solving

Education

Bachelor's degree in Engineering, Life Sciences, or related discipline

Job description

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.