We use cookies. Find out more about it here. By continuing to browse this site you are agreeing to our use of cookies.
#alert
Back to search results
New

QualityEngineer

Spectraforce Technologies
United States, Massachusetts, Westford
Mar 24, 2026
Position Title: Quality Engineer

Work Location: Westford MA

Assignment Duration: 12 months (possibility of extension)

Work Arrangement: Onsite


  • The purpose of this position is to initiate medical device quality assurance activities.
  • These activities must be in accordance with FDA Quality System Regulation, ISO13485 and other international standards.
  • This position will also support device complaint investigation and failure analysis as required.
  • Essential Duties and Responsibilities:
  • Develop incoming inspection processes and document incoming inspection activities.
  • Provide in-process QA support to include inspection and document review.
  • Complete final acceptance activities.
  • Manage the sterilization process, including validations and product sterile loads.
  • Track nonconforming material and lead Material Review Board (MRB) efforts.
  • Interface and take lead QA role in interactions with suppliers, contractors and consultants that supply components, subassemblies and contract processing.
  • Lead complaint investigations on returned product.
  • Manage corrective action and quality improvement activities.
  • Manage aspects of internal quality system relating to receiving inspection, calibration, MRB, etc. Assist in the performance of quality system internal auditing. Support quarterly management review meetings.
  • Establish, monitor and evaluate quality system metrics.


Additional Details

  • 2-3 years minimum of Quality Engineering experience, preferrable in Medical Device Manufacturing.
  • I will accept experience in Pharma or Electronics.
  • Relevant experience must be in a highly regulated industry.
  • They should have experience with working on and executing tasks for projects, risk review, CAPA, and problem solving.
  • Please don't submit candidates with 15 years' experience or have recently held Manager or above jobs, as they will be considered overqualified.
  • Skills: Risk assessment review, Correct/Preventative Actions, inspection plan creation, documentation change management, problem solving/DMAIC, project management, time management
  • General Description of Work:
  • This candidate will be working on several high quality impacting projects at the Westford Manufacturing facility.
  • They will be a part of our post-market "Sustaining Quality Engineering" team and be supporting projects related to post-market updates to our products.
  • This includes maintenance of risk documentation, MPIs, design change evaluations, and support of complaint investigations and analysis.
  • This person will be expected to be prompt, organized, independent, and an aggressive problem solver.
  • We need a candidate with a proven track record of coming up to speed quickly, strong work ethic, and a dedication to supporting life-saving medical devices



Applied = 0

(web-bd9584865-vpmzc)