Senior Director, Quality Assurance-CA (opens in new tab) San Diego, CA →

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

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

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

Compensation: $175,000 - $200,000

• PURPOSE OF POSITION
• Provide strategic and operational leadership for the Quality function supporting the San Diego Medical 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