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Senior Director, Quality Assurance-CA

Synchron

San Diego, CAJobPosted 1w agoStill listed 5 days ago

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At a glance

Compensation
No compensation found
Location
San Diego, CA
Work Authorization
Not specified

Olive lists jobs from US employers, including remote roles you can work from the United States.

Requirements

Credentials this posting asks for.

Bachelor's degree

Job overview

The Senior Director will provide strategic and operational leadership for the Quality function supporting the San Diego Transvascular program. The role is accountable for building and sustaining a compliant Quality Management System from product development through clinical studies, regulatory approval, and commercial launch, and serves as the senior Quality leader on the site leadership team. A bachelor’s degree and extensive medical-device Quality experience are required; an advanced degree and listed certifications are preferred.

Skills & qualifications

RequiredNice to have

Skills

Quality AssuranceLeadershipRegulatory ComplianceQuality Management SystemsFood RegulationsStrategic PlanningRisk ManagementFDA 21 CFR Part 820 (QMSR)ISO 13485ISO 14971EU MDRIEC 60601IEC 62304Executive CommunicationRisk-Based Decision-MakingInfluence Without AuthorityOrganizational ChangeCross-Functional Alignment

Qualifications

Bachelor's in Engineering, Life Sciences, or Related Technical FieldMaster's, MBA, or Equivalent15+ Years Quality Experience7+ Years Leadership ExperienceClass III or Active Implantable Device ExperienceFDA Inspection and Notified Body Audit ExperienceDepartmental Budget and Resource Planning ExperienceASQ CQE, CMQ/OE, or ISO 13485 Lead Auditor Certification

Full job description

  • 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.

How this job compares

Set against the 4,975 open Quality Assurance jobs on Olive Jobs, counted October 27, 2026.

Pay
  • This postingNot listed
  • California median$110–159K/yr247 salary ranges
  • California median$28–36/hr102 hourly ranges
Openings
Olive Jobs lists 437 open Quality Assurance jobs in California and 4,975 across the US. 3% of them nationwide are listed as remote or flexible.
Hiring the most in California
Experience
This posting asks for at least 15 years of experience — more than three in four Quality Assurance postings that state a minimum ask for (median 5 years, across 3,842 postings).
Education
This posting asks for a bachelor's degree; 1,823 of the 4,975 open Quality Assurance jobs (37%) ask for a bachelor's degree or higher.

Counted across the open, public US postings on Olive Jobs on October 27, 2026. Pay medians are the middle values of the low ends and of the high ends of postings that list both ends of a range in the same cadence (a yearly salary or an hourly rate); a range's midpoint is halfway between its ends. Pay and experience figures resting on fewer than 20 postings are left out.

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