Senior Director of Quality Assurance: QMS & Compliance

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

Descrizione del lavoro

Synchron, Inc. in San Diego, CA seeks a Senior Director of Quality Assurance to lead the Quality function from product development through clinical studies, regulatory approval, and commercial launch.

As a member of the site leadership team, you will ensure patient safety and product quality, build and scale a compliant QMS, oversee FDA inspections and Notified Body audits, and manage budgets and resources for rapid execution.

Competenze

• Bachelor’s degree in Engineering, Life Sciences, or related technical field required.
• MS/MBA or equivalent advanced degree preferred.
• Minimum 15 years of quality experience in the medical device industry, including 7+ years in progressive leadership roles.
• Experience hosting FDA inspections and Notified Body audits with successful outcomes.

Mansioni

• Provide strategic and operational leadership for the Quality function from development through commercial launch.
• Serve as senior Quality leader on the site leadership team to ensure patient safety, product quality, and regulatory readiness.

Conoscenze

FDA 21 CFR Part 820

ISO 13485

ISO 14971

EU MDR

IEC 60601

IEC 62304

Executive presence

Formazione

Bachelor's degree in Engineering, Life Sciences, or related field

Advanced degree (MS, MBA, or equivalent) preferred

Descrizione del lavoro

Synchron, Inc. in San Diego, CA seeks a Senior Director of Quality Assurance to lead the Quality function from product development through clinical studies, regulatory approval, and commercial launch.

As a member of the site leadership team, you will ensure patient safety and product quality, build and scale a compliant QMS, oversee FDA inspections and Notified Body audits, and manage budgets and resources for rapid execution.