Medical Device Quality Engineer: CAPA, Risk & Audits
Job in
Blue Ash, Hamilton County, Ohio, USA
Listed on 2026-07-15
Listing for:
Creative Solutions Services, LLC
Full Time
position Listed on 2026-07-15
Job specializations:
-
Quality Assurance - QA/QC
Quality Engineering, Regulatory Compliance Specialist
Job Description & How to Apply Below
Creative Solutions Services, LLC is seeking a Medical Device Quality Engineer with 4+ years of experience to support QMS in regulated environments. You will apply FDA 21 CFR Part 820, ISO 13485, ISO 14971 to drive quality-compliant product development, investigations, and CAPA.
You will collaborate across Quality, Manufacturing, Regulatory Affairs, and Design to ensure timely completion of validations, risk assessments, and audits, with a focus on post-market surveillance and continuous
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