- Experience
- Any
- Salary
- USD 190,000 – USD 250,000 / year
- Openings
- 1
- Posted
- 5 days ago
- Work mode
- In office
- Resume
- Required to apply
Where you'll work
Job description
About the Role
Join a fast-growing mid-sized medical device company based in San Diego, CA, focusing on cutting-edge cardiovascular technologies designed to enhance patient outcomes in complex heart disease cases. The company boasts a strong market presence, an expanding pipeline of products, and ongoing investment in innovative next-generation therapies. As the business expands manufacturing capabilities, global reach, and product development, they are looking for a Senior Director of Quality to lead the Quality function and influence the company's future direction.
Key Responsibilities
- Direct strategic oversight of the Quality Management System, ensuring adherence to FDA regulations, ISO 13485, and international quality standards.
- Lead and develop multidisciplinary teams including Quality Systems, Quality Engineering, Supplier Quality, Design Assurance, and Post-Market Surveillance.
- Collaborate closely with Research & Development, Regulatory Affairs, Clinical Affairs, Manufacturing, and Operations departments.
- Act as the primary Quality liaison for FDA inspections, notified body audits, and Medical Device Single Audit Program (MDSAP) audits.
Required Qualifications
- Extensive knowledge of FDA Quality System Regulations, ISO 13485, ISO 14971, and worldwide medical device compliance requirements.
- Experience in cardiovascular, structural heart, electrophysiology, neurovascular, or other Class III implantable medical device sectors.
- Proficiency in design controls, risk management, Corrective and Preventive Actions (CAPA), supplier quality management, process validation, complaint handling, and post-market quality systems.
- Proven track record in leading Quality teams through product development cycles, clinical trials, commercialization phases, and regulatory inspections.
Compensation and Benefits
- Competitive executive salary ranging from $190,000 to $250,000 annually.
- Participation in a long-term incentive plan, including equity and stock options.
- Comprehensive health coverage including medical, dental, and vision plans.
- 401(k) retirement plan with company matching contributions.
- A significant leadership opportunity within an innovative, high-growth medical device enterprise.