Validation Engineer

Job Duties

  • Support production on the manufacturing floor, ensuring adherence to procedures and ensuring appropriate device history record (DHR) documentation.
  • Support the NC and CAPA processes by completing risk assessments, root cause investigations, and action plans.
  • Reviews qualifications, validations, and other studies for technical content, statistical and sampling rationale, unintended impact and clarity.
  • May participate on design transfer and improvement project teams.
  • Demonstrates commitment to the development, implementation and effectiveness of Quality Management System per ISO, FDA, and other regulatory agencies.
  • May participate on design transfer and improvement project teams.

Basic Qualifications

  • Bachelor’s Degree in Engineering, Chemistry, Biotechnology, Life Science or other technical field and at least 1+ years’ experience in the medical device or other regulated industry.

Preferred Qualifications

  • 2+ years’ experience in the medical device or other regulated industry.
  • Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA) Certification
  • Knowledge of Agile programs. Working knowledge of Database software; Internet software; Spreadsheet software and Word Processing software.
  • Working knowledge of FDA, CGMPs/QSR and ISO quality system requirements. Strong technical writing.
Validation Engineer
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