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Quality Assurance Engineer

Quality Assurance Engineer

Job ID 
Job Locations 
Quality, Regulatory Affairs, and Service

More information about this job


This individual will support the Operations Organization and Post Market Surveillance Organizations with quality improvement and corrective/preventative action programs with other departments in a cross functional environment.  Individual will be a self-starter and decision-maker.


  • Lead multi-discipline product quality teams and participate in New Product Introduction projects.
  • Develop and implement quality improvement
  • Ability to lead product quality investigations to a successful conclusion.
  • Investigate causes of quality and yield problems identified in Incoming Inspection, Manufacturing processes and Final QA
  • Interface with other departments as necessary to provide assistance in CAPA execution.
  • Collect, analyze and disseminate quality data throughout the
  • Participate in Change Control Review and Material Review Board activities.
  • Ensure that all work activity is performed in accordance with established internal procedures, ISO and FDA's Quality System
  • Coordinate departmental functions with those performed in other departments to ensure smooth workflow and timely completion of
  • Plan and conduct internal process audits, support supplier audits, and facilitate UL/ETL/TUV factory audits.
  • Execute risk assessments, collect supporting information and provide recommendations for executive management consideration.
  • Provide support in product investigations.


  • Minimum 5 years related experience in a regulated environment, preferably medical device
  • Excellent written, verbal, time management and interpersonal communications skills
  • ASQ Certified Quality Engineer desirable
  • Familiar with mechanical and electronic test equipment
  • Familiar with Statistical Analysis to analyze data and identify trends
  • Experience with ISO 9001, ISO 13485, 15014971 and FDA QSR for Medical Devices
  • Proficient with MS Office and familiar with Oracle, Agile and Minitab
  • Ability to travel up to 20%, domestic and international, for customer investigations and escalations



  • Four year engineering degree

 ZOLL Medical Corporation appreciates and values diversity.  We are an Equal Oppotunity Employer M/F/D/V.