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Senior Medical Device Quality Engineer – Regulatory & Risk

Listing for: Katalyst CRO
Full Time position Listed on 2026-11-13
Job specializations:
Salary/Wage Range or Industry Benchmark: 110000 - 170000 USD Yearly USD 110000.00 170000.00 YEAR

Job Description & How to Apply Below

Katalyst CRO is seeking an experienced Senior Quality Engineer with expertise in Medical Device Quality Engineering and Regulatory Compliance. The ideal candidate will have hands-on experience in medical device quality systems, risk management, complaint handling, post-market surveillance, CAPA, and regulatory compliance.

This role supports product development, manufacturing, validation, and quality assurance activities while ensuring compliance with FDA regulations, ISO standards, and global

The Senior Medical Device Quality Engineer – Regulatory & Risk role at Katalyst CRO is now open for applications in Santa Clara, CA, United States.

The advertised compensation is 110..

We aim to respond to suitable candidates as soon as possible.

Full responsibilities and requirements are described in the listing above.

Learn more about the Senior Medical Device Quality Engineer – Regulatory & Risk role in the description above.

Position Requirements

10+ Years work experience
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