Synchron
Our vision is to transform medicine with unprecedented access to brain data. A breakthrough platform launching a new field of medicine.
- Open roles
- 17
- New role every
- ~8.2 days
- Posting trend
- 2.8× vs prior 90d
Company signals
Score: 79Job facts
- Location
- San Diego, California, United States of America
- Type
- Full-time
- Salary
- $175K – $200K
- Posted
- Oct 26, 2026
Last verified live 16 hours, 19 minutes ago · checked directly on the company's ADP Workforce Now
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Senior Director, Quality Assurance-CA
at Synchron
- 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.
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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.
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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.
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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.