Senior Director of Quality
Role: Senior Director of Quality
Location: Minneapolis, MN (Hybrid - open to relocating candidates)
Salary: $185,000 - $225,000
EPM is partnered with a rapidly growing, mid-sized medical device company focused on developing innovative cardiovascular and implantable medical technologies. With a strong portfolio of commercialized products and a robust pipeline supporting next-generation therapies, the organization is entering a pivotal phase of growth and commercialization. As they continue to expand their market presence, they are seeking a Senior Director of Quality to provide strategic leadership across the Quality organization and help drive operational excellence, regulatory compliance, and product quality across the business.
Responsibilities:
- Provide strategic leadership for the company's Quality Management System, ensuring compliance with FDA regulations, ISO 13485, ISO 14971, and global regulatory requirements.
- Lead and develop Quality functions including Quality Engineering, Design Quality, Supplier Quality, Manufacturing Quality, and Quality Systems.
- Partner closely with R&D, Regulatory Affairs, Clinical, Manufacturing, and Operations teams to ensure quality is embedded throughout the product lifecycle.
- Lead regulatory inspection readiness efforts and serve as the primary Quality representative during FDA inspections, notified body audits, and international regulatory assessments.
- Drive continuous improvement initiatives, quality metrics, risk management activities, and supplier quality strategies to support product development and commercial growth.
Qualifications:
- Strong knowledge of FDA Quality System Regulations, ISO 13485, ISO 14971, and global medical device regulatory requirements.
- Prior experience within cardiovascular medical devices, implantable devices, cardiac rhythm management, structural heart technologies, neuromodulation, or other Class III medical device environments.
- Demonstrated expertise in design controls, risk management, CAPA, supplier quality, process validation (IQ/OQ/PQ), complaint handling, and post-market surveillance activities.
- Proven track record leading Quality organizations through product development, clinical studies, regulatory approvals, commercialization, and post-market support.
- Bachelor's degree in Engineering or related technical discipline; advanced degree preferred.
Benefits:
- Competitive compensation package
- LTIs
- Medical, dental, and vision insurance
- 401(k) with company match
- Relocation assistance available
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