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Principal Quality Assurance Engineer

Location: Chelmsford, MA

Resuscitation

Overview

ZOLL Medical is a growing, innovation-driven company on the forefront of delivering medical devices to save lives, and software solutions to improve efficiency. With customers in more than 140 countries, we continue to expand our reach, as well as our product offerings. Hospitals, emergency medical services (EMS), and others trust us to provide high-quality products and exceptional customer service. ZOLL products are used every day across the globe to save the lives of people who suffer sudden cardiac arrest. From Real CPR Help® technology—an industry first—to the world’s only wearable defibrillator, our capabilities and features set us apart. But none of this would be possible without the motivation and dedication of ZOLL employees, and we’re invested in their success.

 

We offer competitive salaries and a comprehensive benefits package. Join our team. It’s a great time to be a part of ZOLL!

 

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.

Responsibilities

  • 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

 

Qualifications

  • Minimum 5 years related experience in a regulated environment, preferably medical device
  • Excellent written, verbal, and interpersonal communication
  • Working knowledge of product design verification/validation, reliability, and manufacturing tools validation techniques.
  • Familiar with mechanical and electronic test
  • 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

 Education:

  • Four year Engineering degree
  • Training in Quality Problem Solving tools and Statistical Analysis

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. 

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