Returning Candidate?

Quality Assurance Engineer

Quality Assurance Engineer

Job ID 
2018-1128
Job Locations 
US-MA-Chelmsford
Category 
Quality, Regulatory Affairs, and Service
Type 
Full-Time/Regular

More information about this job

Overview

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, 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

 

Education:

  • Four year engineering degree