What are the responsibilities and job description for the Director of Quality position at EPM Scientific?
Director of Quality
Location: San Francisco, CA
Industry: Medical Devices
We are partnering with a growing medical device company based in San Francisco, CA, dedicated to delivering high‑quality products that improve patient outcomes. With multiple new product lines launching, the organization is expanding its Quality Leadership team and seeking a seasoned Director of Quality to play a critical role in shaping quality strategy and execution.
This is an exciting opportunity for an experienced quality leader to make a meaningful impact on both the organization and the healthcare industry.
Key Responsibilities
- Provide strategic and operational leadership across Quality Assurance and Quality Control functions.
- Lead and further develop a robust Quality Management System (QMS) in compliance with FDA, ISO 13485, and applicable global regulations.
- Serve as the quality leader for new product introductions, ensuring quality is embedded throughout the product lifecycle.
- Drive a culture of quality, compliance, and continuous improvement across cross‑functional teams.
- Lead regulatory inspections and audits (FDA, Notified Bodies, and customers) and ensure inspection readiness.
- Oversee CAPA, risk management, supplier quality, and post‑market quality activities.
- Partner with R&D, Manufacturing, Regulatory Affairs, and Operations to balance compliance with innovation.
Requirements
Experience
- Minimum 10 years of Quality Assurance / Quality Control experience within the medical device industry.
- At least 5 years in a leadership role, managing and developing quality teams.
Education
- Bachelor's degree in Engineering, Life Sciences, or a related field required.
- Master's degree preferred.
Certifications
- ASQ CQE, CQA, or similar quality certifications are highly desirable.
Technical Skills
- Proficiency with QMS software systems.
- Strong understanding of statistical analysis tools.
- Hands‑on experience with risk management methodologies.
Preferred Qualifications
- Experience supporting Class II and Class III medical devices.
- Familiarity with international regulatory requirements, including EU MDR, Health Canada, and other global standards.
- Lean Six Sigma certification or equivalent process improvement training.
What We're Looking For
- Proven Leadership: A strategic thinker who can inspire teams, influence cross‑functional partners, and scale quality systems in a growing organization.
- Regulatory Expertise: Deep knowledge of FDA regulations, ISO 13485, and global medical device compliance requirements.
- Problem Solver: Ability to analyze complex quality and compliance challenges, implement effective solutions, and support innovation without compromising regulatory expectations.
Benefits
- Competitive compensation package
- Bonus and long‑term incentive (LTI) opportunities
- Comprehensive medical, dental, and vision insurance
Salary : $190,000 - $230,000