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Manufacturing Quality Engineer in Wes...

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Manufacturing Quality Engineer

LanceSoft, Inc. Westford, MA (Onsite) Full-Time

Job ***** Manufacturing Quality Engineer

***** Westford, MA

***** 12 Months


Experience **

  • Writes and revises SOPs, controlled forms, and related documents to ensure best practices and maintain compliance.
  • Own Corrective Action/Preventive Action (CAPA) investigations.
  • 2-4 years working experience on similar roles.
  • Statistical techniques knowledge (DOE, SPC) is required.
  • Computer software knowledge (Microsoft Word, Excel, Power Point).
  • Fluency of English (written and speaking) required.
  • Desired experience in validation plans for medical industry products and processes and root cause problem solving methodologies
  • Knowledge of FDA, GMP and ISO guidelines desired.


** Bachelors Degree


Preferred *****

  • Bachelor’s or advanced degree in Mechanical or Biomedical Engineering
  • Prior experience with Cardiovascular & Catheter medical devices
  • Familiar with 21 CFR Part 820, ISO 13485, ISO 14971, EUMDR, and MDSAP.

Recommended Skills

  • Corrective And Preventive Action (Capa)
  • English
  • Iso 13485
  • Iso 14971
  • Medical Material
  • Microsoft Excel

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Job ID: db01eb64-1c36-4375-96f9-8c

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