Senior Quality Systems Engineer

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.