Quality Engineer
$90k - 110k per year
MedTech & Medical Devices
Minneapolis, Minnesota, United States
Permanent
On-site
Overview:
Looking for a hands-on Quality Engineer to support manufacturing and ensure compliance with ISO 13485 and FDA regulations. This role is highly cross-functional and focused on process validation, QMS, and production quality.
Key Responsibilities:
- Lead/support process validation (IQ/OQ/PQ, TMV, qualifications)
- Manage non-conformances, CAPA, and complaint handling
- Support manufacturing line quality and in-line inspections
- Maintain and improve QMS (GMP, GDP, audits)
- Assist with process transfers (prototype → production)
- Collaborate with engineering, operations, and suppliers
- Validation activities
Must-Have Experience:
- 2–5 years in medical device quality/manufacturing
- Strong process validation experience (IQ/OQ/PQ)
- QMS knowledge (ISO 13485, FDA)
- Experience with CAPA, non-conformance, audits
- Comfortable in fast-paced, multi-project environments
Nice to Have:
- Catheter experience
- Contract Manufacturing background
- Class II/III device experience
Perks:
Bonus eligible, PTO, sick time, paid holidays, 401k match
Apply
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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.
