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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.

Quality Manufacturing Engineer

 

IMPACT and OPPORTUNITY

 

As a Quality Manufacturing Engineer with Gentherm Medical, you have the unique opportunity to ensure our broad range of innovative medical devices are safe, compliant, and effective. Every day will present an opportunity to learn and do more. This role is a critical liaison between our Engineering and Manufacturing teams to ensure the highest quality standards for our products and our patients. The idea candidate is detailed oriented, has process experience and is proactive and takes initiative to resolve issues quickly.  The employee will have the authority to ensure ISO 13485, 21CFR820 and other applicable regulations are followed.

 

ESSENTIAL FUNCTIONS AND RESPONSIBILITIES

 

  • Functions as the subject matter expert for quality manufacturing processes including:
    • Sterilization and Clean rooms
  • Ensures FDA and ISO 13485 compliance in manufacturing
  • Provides supports for QMS processes including:
    • CAPA investigations and Production & Process Controls
    • Control of Non-Conforming
    • Engineering Change Control
  • Identify needs for process improvements, fixtures and automation as needed.
  • Improve productivity and efficiency by providing ongoing training for new production processes and methods.
  • Work with operations team to ensure finished products meet customer specifications.
  • Work with manufacturing team to solve production related issues.
  • Participate in production equipment selection and assessment.
  • Develop and complete IQ, OQ and PQ for production equipment, fixtures and tooling.
  • Develop process controls for production equipment; write equipment standards. Specify maintenance and calibration requirements.
  • Establish and monitor building maintenance requirements
  • May assist in shop floor layout and manufacturing process design
  • May assist or lead with development of pFMEA and dFMEA documents
  • May assist in troubleshooting and repair of manufacturing equipment.

QUALIFICATIONS

 

MINIMUM QUALIFICATIONS:

 

  • Bachelor’s degree in Mechanical or Biomedical Engineering
  • Minimum of 5 years of experience in quality.
  • Basic knowledge of ISO 13485 and 21 CFR 820.
  • Possesses project management, problem-solving and verbal & written communications skills.
  • Able to analyze and trend data to facilitate continuous improvement efforts within production and assure effectiveness of the product.

 

PREFERRED QUALIFICATIONS:

 

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

NICE TO KNOW

 

TRAVEL: Local

 

LEADERSHIP RESPONSIBILITIES: As necessary with projects

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

 

#LI-TO1

PHYSICAL DEMANDS/WORK ENVIRONMENT

 

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:  7616
Location: 

Cincinnati, OH, US, 45241

Country/Region:  US
Published:  Jul 17, 2021


Nearest Major Market: Cincinnati

Job Segment: Industrial, Quality Engineer, Medical, Quality, Manufacturing, Engineering, Healthcare