Quality Engineer

Devens, MA
Job Requisition: 6995.1

Quality Engineer (Direct Hire)

Devens, MA

Job Requisition: 6995.1

Description for Quality Engineer:

As the Quality Engineer you will be a hands-on engineer involving metal additively manufactured parts. Will have oversight of production related medical device quality projects from concept to shipping. Will include a large amount of validation work for new manufacturing lines. Hands on role on the floor, managing production related issues.

Responsibilities for Quality Engineer:

  • Lead the FDA medical product development for the Quality Management System.
  • Ensure the IQ, OQ, and PQ process meets customer expectations and is integral to Quality Management System.
  • Develop, communicate, and implement Quality Standards.
  • Assist the Quality Engineering Manager in assuring the QMS conforms to the customer, internal, industry (ISO 13485), and regulatory/legal requirements by conducting audits and identifying gaps.
  • Assure Inspecting and testing materials, equipment, processes, and products meet quality specifications.
  • Collaborate to develop and implement quality and process controls and improvements.
  • Assure that calibration methods meet customer requirements and industry standards.
  • Investigating and troubleshooting product or production issues
  • Lead the inspection of manufactured parts, issue non-conformance reports, and facilitate the disposition of MRB hardware and corrective action tasks.

Requirements for Quality Engineer:

  • Bachelor's degree in engineering or a related field is required
  • Knowledge of medical product quality management qualification systems
  • 1-2+ years experience of IQ, OQ, and PQ process
  • 2+ years of experience in medical product development and Quality System creation
  • 2+ years of experience in Quality Assurance/Quality Control
  • First Article and inspection method creation
  • Knowledge of 13485 Quality Management System 
  • Knowledge of GMP, FDA QSR, and MedAccred requirements
  • Root Cause Analysis, Data analysis, and Statistical Process Control

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