Your Career. Your Impact. Your Future. At Gentherm, we believe the next big breakthrough begins with you. As a global leader in thermal management and pneumatic comfort technologies, we develop advanced systems that deliver meaningful solutions to enhance health, wellness, comfort, and efficiency in everyday life. Our products and innovations are created for you, by you. Be part of our team where a human-centric mindset drives everything we do-from the technologies we build to the careers we support. With decades of expertise, we have pioneered advanced solutions that have become a standard expectation for consumers around the world. The same thoughtful approach we take in developing our technologies guides how we support your career: purposeful, impactful, and tailored to you. Because when you thrive, innovation thrives. 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 amanda.wylonis@gentherm.com Ref 573858 MINIMUM QUALIFICATIONS PREFERRED QUALIFICATIONS NICE TO KNOW Gentherm is an Equal Opportunity Employer. We are committed to building an inclusive culture through Our Network of Engagement (ONE) where we value our differences and work together to positively impact the lives of our employees, customers, and communities. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, national origin, genetic information, sexual orientation, gender identity, disability, or protected veteran status. Gentherm is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, national origin, genetic information, sexual orientation, gender identity, disability or protected veteran status.