JOB TITLE

Senior Quality Engineer

ESSENTIAL FUNCTIONS AND RESPONSIBILITIES

Senior Quality Engineer for Cincinnati, OH medical device manufacturer to maintain and improve Quality Management System to meet regulatory requirements; lead risk management activities; provide regulatory support during new product development; assist with CAPA & post-market surveillance activities; support verification & validation testing and change control; drive continuous improvements. Requires Bachelor's in Biomedical Engineering or closely-related field & 3 yrs experience in medical device engineering position(s): performing medical device design control during all phases of the product lifecycle, including creating & coordinating Design History Files (DHF), conducting design verification, and authoring design requirements; applying risk management methodologies, including FMEA & hazard analysis; ensuring product compliance with ISO 14971 & 13485 standards and U.S. and international medical device regulations, including EU MDR; and supporting Notified Body audits & FDA inspections, including performing document management & coordinating responses to observations and findings. Position may telecommute from location within reasonable commuting distance of Cincinnati, OH up to 1 day per wk. Mail resume to Gentherm Medical, LLC, Attn: A. Wylonis, 28875 Cabot Dr, Novi, MI 48377 or email resume to [redacted] Ref 573858

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Job Req ID: 10078

Country/Region: US

Published: Jul 28, 2026