- PURPOSE OF POSITION
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- 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.
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- ESSENTIAL FUNCTIONS
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- MINIMUM EDUCATION
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- Bachelor’s degree in Engineering, Life Sciences, or a related technical field required.
- Advanced degree (MS, MBA, or equivalent) preferred.
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- MINIMUM EXPERIENCE
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- 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.
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- LICENSES, CERTIFICATIONS, REGISTRATIONS
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- ASQ Certified Quality Engineer (CQE), Certified Manager of Quality/Organizational Excellence (CMQ/OE), or ISO 13485 Lead Auditor certification preferred.
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- OTHER ESSENTIAL KNOWLEDGE, SKILLS, AND ABILITIES
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- 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.
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