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Quality Assurance Engineer

Quality Assurance Engineer

Job ID 
2018-1236
Job Locations 
US-MA-Chelmsford
Category 
Quality, Regulatory Affairs, and Service
Type 
Full-Time/Regular

More information about this job

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!

 

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.

Responsibilities

  • 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.

Qualifications

  • 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, ISO 14971 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

 Education:

  • Four year engineering degree

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.