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.

IMPACT and OPPORTUNITY

Provides independent, objective assurance and advisory services, designed to add value and minimize risk for Gentherm Medical. This will be accomplished by designing and implementing risk-based audit programs, policies, and practices that look beyond simply assessing the single element being investigated, but rather the interaction with other systems and the effectiveness on achieving planned results.

ESSENTIAL FUNCTIONS AND RESPONSIBILITIES:

  • Supports Gentherm's Mission Statement, Vision Statement, Quality Policies.
  • Process owner and subject matter expert for the Quality Management System Audit Processes. 
  • Conduct internal quality system audits and supplier quality audits.
  • Create and maintain internal/supplier audits schedule. Manager internal audit program.

  • Support CAPA, SCAR, etc. related to audits until the closure of audit findings. Serve as CAPA coordinator.

  • Assure Gentherm's internal or contracted auditors are adequately trained and qualified to perform assigned audits by virtue of their training, education and experience.

  • Communicate and coordinate audit activities with other departments.

  • Recommend and implement improvements to audit programs driven by new regulations, industry standards, new technologies, and internal business needs.

  • Maintain current knowledge of and compliance with the full range of related quality systems, technology, regulatory requirements, and related policies and procedures.

  • Complete required documentation, files, reports and records in a timely manner.

  • Maintain appropriate metrics to ensure the success of auditing and compliance activities.

  • Monitor regulatory agency activities associated with the Medical Device industry and assess its impact on trends and business focus.

  • Plans, organizes, and provides training related to Quality Management System auditing and regulatory compliance, as necessary.

  • Assist in preparation, analysis, and presentation of Quality indicator metrics to Management Review meetings.

  • Performs other related duties and responsibilities, as assigned.

MINIMUM QUALIFICATIONS:

  • Bachelor’s Degree
  • 5+ years in the medical device industry or related GMP environment or equivalent
  • 3+ years’ experience in quality system compliance audits
  • ASQ Certifications for Auditing and/or Quality Management
  • Medical Device Internal Audit experience
  • Thorough knowledge and understanding of medical device regulations and standards, including but not limited to US FDA Quality System Requirements (QSR), Medical Device Single Audit Program (MDSAP) and their associated country regulations. European Medical Device Directive/Regulation (MDD/MDR), ISO 13485:2016, and other applicable industry requirements. Documented training and/or experience must be available.
  • Excellent verbal and written communication skills, including attention to detail; strong questioning and listening skills; and the ability to look beyond obvious answers to understand the impact on other areas.
  • Must have ability to make effective presentations to all levels of the organization.
  • The proven ability to prioritize, manage multiple projects, and meet deadlines in a timely manner.
  • Must have the ability to work in both a collaborative (team) environment as well as perform independent work.
  • Knowledge of computer programs such as Microsoft Office (Word, Excel, PowerPoint, and Outlook).

PREFERRED QUALIFICATIONS:

  • Project management or Six Sigma Green Belt training

COMPETENCIES:

  • Deliver Results
    • Understand the mission and output of your team; set SMART objectives and deliver
  • Drive Change
    • Focus on agility and commitment to continuous improvement; Understand and act on internal and external drivers of change
  • Build Capability
    • Foster a culture of learning and development; Support individual growth through continuous feedback to achieve personal and professional goals
  • Cultivate Innovation
    • Openly embrace, create, implement and support new and innovative ideas, processes and technology that deliver business results

 

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.

Job Req ID:  9205
Country/Region:  US
Published:  Feb 5, 2024


Nearest Major Market: Cincinnati

Job Segment: Internal Audit, Audit, Medical Device, Compliance, Quality Manager, Finance, Healthcare, Legal, Quality