Manufacturing Quality Engineer
$40 - 45 per hour
MedTech & Medical Devices
Minnesota, United States
Contract
On-site

Responsibilities:

  • Support product release activities in compliance with FDA QSR and ISO 13485
  • Author, execute, and review validation documentation (IQ/OQ/PQ, process and packaging validations)
  • Prepare and maintain controlled engineering documentation, protocols, reports, and change records
  • Support sterile barrier system validation activities, including seal strength, integrity, and package performance testing
  • Collaborate cross-functionally with Quality, Manufacturing, and Regulatory teams to ensure release readiness

Qualifications:

  • Bachelor’s degree in Engineering
  • 3+ years of experience in a regulated medical device environment
  • Hands-on experience with validation and controlled documentation
  • Familiarity with thermoforming and package sealing processes is a strong plus
  • Experience supporting packaging process validation and product release activities

 

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