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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 leader in thermal management technologies we embrace the opportunity to create and deliver extraordinary thermal 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

The Complaint Investigator role supports Gentherm’s Complaint Handling activities.  Medical Device regulations require that complaints are received, reviewed, and evaluated in a uniform and timely manner.  When evaluation determines that an investigation is required, the Complaint Investigator reviews the available information, identifies root cause of the failure, and completes a risk assessment.  This role supports ongoing monitoring activities to identify trends and can initiate actions to reduce complaint rates, if needed.

ESSENTIAL FUNCTIONS AND RESPONSIBILITIES:

General:

  • Performs assigned duties to support Quality Assurance/Regulatory Affairs (QA/RA) and meet Quality Objectives
  • Provides Quality support for Gentherm products
  • Conducts investigations to support the Quality Management System
  • Plans, prioritizes, and performs duties, as assigned

 

Complaint Handling:

  • Analyzes data to monitor complaint rates for trends and facilitate continuous improvement
  • Works cross-functionally and with suppliers to support investigation efforts
  • Conducts investigations and documents technical investigative reports to include Root Cause Analysis, Risk Assessment and Trending
  • Effectively communicates and presents information such as project updates, data/trending information, etc.
  • Analyzes and transforms data into actionable information and leads projects
  • Submits Medical Device Reports to Regulatory Authorities

 

Approval authorizations upon delegation:

  • Investigation documentation
  • Sort/rework plans
  • Document Change Requests (DCRs)
  • Test protocols and reports
  • DMR and DHF documents
  • Labeling reviews

MINIMUM QUALIFICATIONS:

  • Bachelor of Science or equivalent experience
  • A minimum of 3 years of Quality or Regulatory experience, preferably within the medical device or pharmaceutical industry or a related healthcare field 
  • Experience with complaint handling, root cause/failure analysis and risk management
  • Experience analyzing data, including tracking/trending
  • Problem-solving, verbal and written communication skills
  • Experienced with Microsoft Office products, able to read and understand technical documents

PREFERRED QUALIFICATIONS:

  • Experience in a regulated industry, preferably medical device or pharmaceutical
  • Thermal management experience
  • Project leadership
  • Familiar with MDSAP, Regulation (EU) 2017/745, ISO 13485, 21 CFR Part 803 and 820, IMDRF categorization
  • CQE

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:  7165
Location: 

Cincinnati, OH, US, 45241

Country/Region:  US
Published:  May 14, 2022


Nearest Major Market: Cincinnati

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