Senior Director, Quality Assurance-CA

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.

ESSENTIAL FUNCTIONS

MINIMUM EDUCATION

Bachelor’s degree in Engineering, Life Sciences, or a related technical field required.

Advanced degree (MS, MBA, or equivalent) preferred.

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.

LICENSES, CERTIFICATIONS, REGISTRATIONS

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

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.