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Manufacturing Quality Engineer

LanceSoft, Inc.
Westford, MA Full Time
POSTED ON 1/21/2025
AVAILABLE BEFORE 4/20/2025

Job Title : Manufacturing Quality Engineer

Location : Westford, MA

Duration : 12 Months

Experience Details :

  • 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.

Education : Bachelors Degree

Preferred Qualifications :

  • 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.
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