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Postmarket Quality Lead: CAPA & Complaints; IVD

Job in Irvine, Orange County, California, 92602, USA
Listing for: Regulatory Toolkit
Full Time position Listed on 2026-11-12
Job specializations:
Salary/Wage Range or Industry Benchmark: 134000 - 170000 USD Yearly USD 134000.00 170000.00 YEAR

Job Description & How to Apply Below

Position: Postmarket Quality Lead: CAPA & Complaints (IVD)

Freenome is seeking a senior quality leader to own the postmarket complaint handling program and CAPA across regulated environments. Based in Brisbane, CA, this onsite role collaborates with teams to ensure customer feedback is captured and acted on, and serves as the quality interface with commercial partners.

You will mentor junior staff, drive root-cause analysis, and ensure CAPA records, trend analyses, and regulatory documentation meet 21 CFR 820/QMSR and ISO 13485 requirements.

We are looking to fill the Postmarket Quality Lead: CAPA & Complaints (IVD) position at Regulatory Toolkit in CA, United States.

Full responsibilities and requirements are described in the listing above.

Learn more about the Postmarket Quality Lead: CAPA & Complaints (IVD) role in the description above.

We appreciate your interest in this position.

Join Regulatory Toolkit and contribute to our ongoing work.

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