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Principal Quality Assurance Engineer

Location: Chelmsford, MA

Resuscitation

Job Summary:

This individual will support the Operations Organization and the Post Market Surveillance group with quality improvement and corrective/preventative action programs. Interface with R&D to support New Product Introductions in a cross functional environment.

Essential Functions:

  • Lead multi-discipline product quality teams for investigations and continuous improvement
  • Develop and implement quality improvement programs
  • Investigate causes of quality and yield problems identified in the field and throughout the manufacturing processes
  • Interface with other departments as necessary to provide assistance in CAPA execution
  • Collect, analyze and disseminate quality data throughout the organization using statistics to identify trends
  • Participate in Change Control and Material Review Board review activities
  • Represent QA in multi-discipline New Product Introduction teams
  • Ensure that all work activity is performed in accordance with established internal procedures, ISO and FDA's Quality System Requirements
  • Plan and conduct internal process audits and support supplier quality audits
  • Facilitate UL/ETL/TUV safety audits and support 3rd party external audits
  • Provide support Health Risk Assessments by collecting supporting information and executing risk assessments

Skills Requirements:

  • Training in Quality Problem Solving tools and Statistical Analysis
  • Excellent written, verbal, and interpersonal communication skills
  • Working knowledge of product design verification/validation, reliability, and manufacturing tools validation techniques
  • Familiar with mechanical and electronic test equipment
  • Experience with ISO 9001, ISO 13485, ISO 14971, and FDA QSR for Medical Devices
  • Ability to travel up to 20%, domestic and international, for customer investigations and escalations

Required/Preferred Education and Experience:

  • Four year Engineering  degree
  • Minimum 5 years related experience in a regulated environment, preferably medical device

Other Duties:

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job.  Duties, responsibilities, and activities will be reviewed periodically as duties and responsibilities change with business necessity.  Essential and marginal job functions are subject to modification.

 

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

 

ADA:  The employer will make reasonable accommodations in compliance with the Americans with Disabilities Act of 1990