Senior Quality Systems Engineer

Gentherm
United States, Ohio, Cincinnati
12011 Mosteller Road (Show on map)
Jun 24, 2025
At Gentherm, we say, "It's about the person." We're with you on a cold winter day when you turn on your heated seat and steering wheel or helping manage patient body temperature in the operating room, recovering room or intensive care units. We take a human approach with everything we do. As the global market leader of innovative thermal management and pneumatic comfort technologies for the automotive industry we embrace the opportunity to create and deliver extraordinary solutions that make meaningful differences in everyday life. We do this by improving health, wellness, comfort and energy efficiency. We embrace an entrepreneurial spirit and combine that with our global leadership to deliver results. Working at Gentherm provides you the opportunity to not only shape the future of the automotive and medical industries, but also influence your career throughout the company. You will be engaged, challenged and inspired by our team to deliver leading thermal technologies that positively impact lives around the world. SENIOR QUALITY SYSTEMS ENGINEER IMPACT and OPPORTUNITY The Senior Quality Systems Engineer (QSE) plays a critical role in maintaining and improving the Quality Management System (QMS) to ensure compliance with regulatory requirements and internal quality objectives while providing risk management leadership and supporting technical document reviews. This role drives continuous improvement initiatives, ensures product and process compliance, supports new product development, and collaborates cross-functionally to uphold the highest standards of quality across Gentherm Medical. ESSENTIAL FUNCTIONS AND RESPONSIBILITIES Leads and manages risk management activities according to ISO 14971. Supports Engineering during new product development while guiding design teams to develop products that meet customer, quality and regulatory requirements. Assist with CAPA and post-market surveillance, including root cause analysis and corrective action planning when necessary. Supports verification and validation testing for new product development. Supports change control processes by ensuring documentation accuracy. Ensures product compliance to applicable processes, standards, and regulations throughout the product lifecycle. Familiar with ISO 13485, FDA Medical Device Regulations, and EU MDR. Drive continuous improvement initiatives to enhance quality system performance, compliance, and operational efficiency. MINIMUM QUALIFICATIONS Bachelor's Degree in Engineering, Life Sciences, or related technical discipline. Minimum 7 years of Quality Engineering experience. 5+ years of experience in the medical device industry per ISO 13485. Strong understanding of ISO 14971, ISO 13485, US and International Medical Device Regulations. Experience with common medical device risk management methodologies (FMEA, hazard analysis, etc.) Strong understanding of CAPA, document control, and change control processes. Expertise in root cause analysis tools such as 5 Whys, Fishbone Diagram, and FMEA. Exceptional written and verbal communication skills. High attention to detail, excellent organization skills, and ability to prioritize effectively. Proficient with Microsoft Office Suite and electronic QMS platforms. Demonstrated ability to analyze and trend data to support continuous improvement initiatives. PREFERRED QUALIFICATIONS Experience in design and development per critical medical device design standards IEC 60601, IEC 62304, and ISO 10993. ASQ Certification (CQE, CQA, or CQM/OE). Experience with software validation, risk management, design controls, and complaint handling. Experience supporting Notified Body audits and FDA inspections. Familiarity with Lean Six Sigma principles. 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.