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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 employee will work with all departments to provide guidance, recommendations and always ensure product quality and compliance.  The employee will have the authority to ensure ISO 13485, 21CFR820 and other applicable regulations are followed.

ESSENTIAL FUNCTIONS AND RESPONSIBILITIES:

  • Performs assigned duties to support the Quality Department and meet Gentherm Quality Objectives
  • Responsible for the compliance and execution of the assigned QMS processes
    • Calibration of Measurement and Test Equipment
  • Supervise and manage Quality test lab
  • Responsible to monitor medical device industry trends for assigned QMS processes
  • Authorized to provide Quality support for assigned Gentherm product lines
  • Responsible for analyzing and trending data to facilitate continuous improvement efforts and effectiveness of assigned product lines
  • Performs investigations as required to support the CRB, MRB, CAPA teams, etc.
  • Responsible for Quality support for assigned development / continuous improvement projects
  • Plans and performs duties as assigned. Work is performed with supervision involving occasional interactions to surpass hurdles
  • Provides direction and leadership relative to assigned QMS processes
  • Effectively communicates and presents information (i.e. able to provide project updates, deliver training, present QMS data/trends to QRB and Management Review, etc.)
  • Resolves operational issues within cross-functional teams
  • Analyzes and transforms data into actionable information
  • Leads projects

MINIMUM QUALIFICATIONS:

  • Bachelor of Science Degree
  • Minimum 3 years of related experience or equivalent
  • Project management, problem-solving skills
  • Excellent verbal & written communications skills
  • Ability to analyze and trend data to facilitate continuous improvement efforts within production and assure effectiveness of product

PREFERRED QUALIFICATIONS:

  • Medical Device or Pharmaceutics background
  • Auditing Background
  • Acceptance Activities Regulations / Requirements
  • Investigations Regulations / Requirements
  • Statistical Techniques Regulations / Requirements

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

PHYSICAL DEMANDS/WORK ENVIRONMENT (US):

All positions in our office require interaction with people and technology while either standing or sitting. In order to best service our customers, internal and external, all associates must be able to communicate face-to-face and on the phone with or without reasonable accommodation. Gentherm is committed to compliance with its obligations under all applicable state and federal laws prohibiting employment discrimination. In keeping with this commitment, it attempts to reasonably accommodate applicants and employees in accordance with the requirements of the disability discrimination laws. It also invites individuals with disabilities to participate in a good faith, interactive process to identify reasonable accommodations that can be made without imposing an undue hardship.

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:  8327
Location: 

Cincinnati, OH, US, 45241

Country/Region:  US
Published:  May 7, 2022


Nearest Major Market: Cincinnati

Job Segment: Quality Engineer, Medical, Thermal Engineering, CAPA, Engineering, Quality, Healthcare, Management