Director of Quality
Role: Director of Quality
Location: San Diego, CA (On-site)
Salary: $180k - $250k
EPM is partnering with an innovative medical device company developing cutting-edge wearable and connected technologies that are helping transform the management of chronic conditions. As the organization continues to scale, they are seeking a Director of Quality to lead and evolve 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 with cross-functional stakeholders across R&D, Regulatory Affairs, Manufacturing, Operations, and Supply Chain.
- Drive Design Assurance activities throughout the product lifecycle, including risk management, verification, validation, and design transfer.
- Oversee CAPA, complaint handling, nonconformance management, internal audits, supplier quality, and post-market surveillance.
- Lead Quality strategy during product development, commercialization, and organizational growth.
- Support regulatory inspections, notified body audits, and customer audits.
- Build, mentor, and develop a high-performing Quality team.
Qualifications
- Bachelor's degree in Engineering, Life Sciences, or a related discipline.
- 10+ years of Quality experience within the medical device industry.
- Prior leadership experience managing Quality teams and cross-functional initiatives.
- Strong working knowledge of FDA Quality System Regulations, ISO 13485, CAPA, risk management, and Design Controls.
- Experience supporting Class II and/or Class III medical devices.
- Experience within wearable devices, diabetes technology, connected devices, digital health, or combination products is highly preferred.
- Demonstrated success supporting products from development through commercialization.
Why This Opportunity?
- Join a rapidly growing organization in a high-growth market.
- Play a key role in bringing innovative wearable technologies to patients.
- Influence Quality strategy at both the operational and executive levels.
- Competitive compensation, bonus, equity, and comprehensive benefits package.
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