Quality Engineer

Employer
Commonwealth Sciences, Inc.
Location
Boston, MA
Closing date
Dec 3, 2021

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Sector
Science, Physical Sciences and Engineering
Position located in Burlington, MA.

Responsibilities of the Quality Engineer:
  • Validate product operations, functions, and failures
  • Isolate, reproduce, and resolve issues found on during production and with external clients
  • Partake in all activities involving QA and regulatory compliance
  • Assist regulatory team with both internal and supplier audits
  • Review SOPs, batch records, change orders, CAPAs, and other documentation related to quality systems
  • Inspect and analyze incoming parts
  • Determine failure modes, risk analysis, and FMEAS


Requirements of the Quality Engineer:
  • BS in engineering related discipline
  • Must have previous experience with medical device or quality inspection experience in other highly regulated industry
  • Experience with high level troubleshooting
  • Candidates should have quality experience with incoming suppliers
  • Previous experience with both internal and external audits

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