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

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