Senior Director, Quality Assurance — Medical Devices

Synchron; San Diego (CA); On-site; USD 175,000 - 200,000; Full time

Job summary

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

Qualifications

• 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.

Responsibilities

• 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.

Skills

QMS leadership

Regulatory readiness

FDA inspections

Notified Body audits

Budget planning

Cross-functional leadership

Quality strategy

Education

Bachelor’s degree in Engineering or Life Sciences

Advanced degree preferred

Job description

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