Engineer, Quality in Westford, MA at Volt

Date Posted: 3/24/2020

Job Snapshot

  • Employee Type:
    Contingent
  • Location:
    Westford, MA
  • Duration:
    24 weeks
  • Date Posted:
    3/24/2020
  • Job ID:
    223968
  • Contact Name
    Volt Branch
  • Phone
    781 932 4280

Job Description

Quality Engineer

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.

Responsibilities:

  • Develop incoming inspection processes and document incoming inspection activities.
  • Perform process validations including IQ, OQ, PQs and write associated protocols, reports.
  • Conduct test method validations (Gage R&R) including assessing suitability of test methods.
  • Review any changes in risk occurrences based on validations and update PFMEAs as needed.
  • Apply Quality Engineering methodologies including root cause investigations.
  • 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.

Qualifications:

  • Candidates must possess 1-3 years’ experience supporting validation programs.
  • BS degree, preferable in the Science or Engineering fields (or equivalent experience).
  • Strong statistical and analytical skills.

Volt is an equal opportunity employer.