Senior Director, Quality Assurance-CA

Synchron; San Diego (CA); In loco; USD 175.000 - 200.000; Tempo pieno

Descrizione del lavoro

Synchron in San Diego seeks a Senior Director of Quality Assurance to lead the Quality function for the Transvascular program. This senior role ensures a compliant QMS from development through regulatory approval and commercial launch, with accountability for patient safety and product quality.

The successful candidate will bring 15+ years in medical device quality, including 7+ years in leadership, with demonstrated experience hosting FDA inspections and Notified Body audits and managing

Competenze

• Bachelor’s degree in Engineering, Life Sciences, or related field.
• Advanced degree (MS, MBA, or equivalent) preferred.
• Minimum 15 years of Quality experience in the medical device industry, incl. 7+ years in leadership.
• Experience hosting FDA inspections and Notified Body audits with successful outcomes.
• Proven track record of managing budgets, resources, and growth.

Mansioni

• Provide strategic and operational leadership for the Quality function across San Diego Transvascular program.
• Ensure patient safety, product quality, and regulatory readiness are integrated into business strategy.
• Build, scale, and sustain a compliant QMS from development through commercialization and launch.

Conoscenze

QMS leadership

Regulatory readiness

FDA inspections

Notified Body audits

Budget planning

Cross-functional leadership

Quality strategy

Formazione

Bachelor’s degree in Engineering or Life Sciences

Advanced degree preferred

Descrizione del lavoro

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Senior Director, Quality Assurance-CA

Clinical Sci+Ops Full Time San Diego, CA, US 1 Attachments

2 days ago Requisition ID: 1048

Salary Range: $175,000.00 To $200,000.00 Annually

• 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.

Attachments (1)

Sr_Director_Quality_Job_Description_10-2026_Draft.docx