Senior Director, Quality Assurance-CA

Job Description

Job Description

1. PURPOSE OF POSITION

• Provide strategic and operational leadership for the Quality function supporting the San Diego Transvascular program, with accountability for building, scaling, and sustaining a compliant Quality Management System (QMS) from product development through clinical studies, regulatory approval, and commercial launch.
• Serve as the senior Quality leader on the site leadership team, ensuring patient safety, product quality, and regulatory readiness are built into business strategy and decision-making.

1. ESSENTIAL FUNCTIONS

1. MINIMUM EDUCATION

• Bachelor’s degree in Engineering, Life Sciences, or a related technical field required.
• Advanced degree (MS, MBA, or equivalent) preferred.

1. MINIMUM EXPERIENCE

• Minimum 15 years of Quality experience in the medical device industry, including at least 7 years in progressive leadership roles managing managers and multidisciplinary teams.
• Demonstrated success building or scaling a QMS from development through commercialization, preferably for Class III and/or active implantable devices.
• Direct experience hosting FDA inspections and Notified Body audits with successful outcomes.
• Proven track record of managing departmental budgets, resource plans, and organizational growth.

1. LICENSES, CERTIFICATIONS, REGISTRATIONS

• ASQ Certified Quality Engineer (CQE), Certified Manager of Quality/Organizational Excellence (CMQ/OE), or ISO 13485 Lead Auditor certification preferred.

1. OTHER ESSENTIAL KNOWLEDGE, SKILLS, AND ABILITIES

• Expert knowledge of FDA 21 CFR Part 820 (QMSR), ISO 13485, ISO 14971, EU MDR, and applicable device standards (e.g., IEC 60601, IEC 62304).
• Strategic thinker able to translate business goals into actionable quality plans, balancing rigorous compliance with speed of development.
• Strong executive presence; communicates clearly and credibly with the executive team, regulators, Notified Bodies, and cross-functional partners.
• Sound, risk-based judgment and decision-making in a fast-paced, evolving environment.
• Proven ability to influence without authority, lead organizational change, and build alignment across functions.