Location: Cincinnati,OH, USA
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. 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:
* 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 and associated metrics. Manage internal audit program.
* Support CAPA, SCAR, etc. related to audits until the closure of audit findings.
* 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.
* Complete required documentation, files, reports, and records in a timely manner.
* Plans, organizes, and provides training related to Quality Management System auditing and regulatory compliance, as necessary.
* Assists in the revision, writing, and/or review of SOPs and work instructions to identify areas of compliance and process improvements.
* 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
* Excellent verbal, written and presentation skills.
* Knowledge of computer programs such as Microsoft Office (Word, Excel, PowerPoint, and Outlook).
PREFERRED QUALIFICATIONS:
* Project management or Six Sigma Green Belt training
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.