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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We are a trusted partner for every step from Discovery through to Development. So, no matter where you are in your journey, we're here to help you make a difference. We are a trusted partner for every step from Discovery through to Development. So, no matter where you are in your journey, we're here to help you make a difference.
