Director of Quality
Director of Quality
Location: South San Francisco, CA | Hybrid (open to strong out‑of‑state candidates)
Salary: $190,000 - $250,000
The Company
We're partnering with a growing, well‑funded cardiovascular medical device company headquartered in Irvine, CA. With multiple new product lines advancing through development and commercialization, the organization is expanding its Quality leadership team to support scale. Quality is highly visible and plays a strategic role across the business.
The Role
This Director of Quality will own and evolve the Quality Management System while serving as a key partner to Regulatory, R&D, Manufacturing, and executive leadership. The role offers the opportunity to influence both strategy and execution during a critical growth phase.
Key Responsibilities
- Lead and enhance the QMS across design, manufacturing, and post‑market activities for Class III cardiovascular devices
- Act as the primary Quality representative for FDA and global regulatory inspections, audits, and agency interactions
- Build, mentor, and develop a high‑performing Quality organization while driving a culture of compliance and continuous improvement
What We're Looking For
- 10+ years of Quality experience within the medical device industry, including meaningful leadership responsibility
- Hands‑on experience supporting Class III devices and cardiovascular products
- Strong working knowledge of FDA QSR (21 CFR 820), ISO 13485, design controls, and risk management
- Ability to balance compliance with innovation in a fast‑moving environment
Nice to Have
- Exposure to international regulations (EU MDR, Health Canada, etc.)
- Experience scaling Quality systems for new products or growing organizations
- Six Sigma, ASQ, or similar certifications
Compensation & Benefits
- Competitive base salary, annual bonus, and long‑term incentive potential
- Comprehensive medical, dental, and vision coverage
- 401(k) and additional benefits typical of a growth‑stage med device company
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