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Quality Engineer

Job in Minneapolis, Hennepin County, Minnesota, 55400, USA
Listing for: SciPro
Part Time position
Listed on 2026-04-02
Job specializations:
  • Engineering
    Quality Engineering, Process Engineer
  • Quality Assurance - QA/QC
    Quality Engineering
Salary/Wage Range or Industry Benchmark: 80000 - 100000 USD Yearly USD 80000.00 100000.00 YEAR
Job Description & How to Apply Below

Schedule: Flexible “summer hours” (4x9hr days + half-day Friday)

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
  • Contract Manufacturing background

Bonus eligible, PTO, sick time, paid holidays, 401k match

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