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Quality Engineer

Quality Engineer

Kelly Science, Engineering, Technology & TelecomTualatin, OR, United States
2 days ago
Job type
  • Full-time
  • Permanent
Job description

Quality Engineer – Medical Devices 📍 Onsite in Tualatin, OR | 💼 Full-Time, Direct Hire |

$115K–$120K + Benefits & Relocation Assistance

About Kelly Engineering

Kelly Engineering partners with leading companies in the medical device industry to connect top talent with opportunities that truly make an impact. Our client is a fast-growing manufacturer of advanced emergency medical solutions used worldwide by both civilian and military professionals.

The Opportunity

We are seeking a Quality Engineer to join a high-performing Quality Assurance team in Tualatin, Oregon. This role is critical in ensuring that life-saving medical products are designed, manufactured, and maintained to the highest standards of compliance and reliability.

Why This Role Stands Out

  • Competitive salary range of $115K–$120K with relocation assistance available .
  • Tiered career paths and growth opportunities — engineers here aren’t stuck, they’re developed.
  • Mission-driven company culture where your work directly contributes to saving lives.
  • Fast-growing environment with interviews moving quickly.

What You’ll Do

  • Lead quality activities for new product development, including design controls, risk management, validation, and design transfer.
  • Develop and maintain quality inspection plans and acceptance criteria.
  • Plan and execute validations (IQ / OQ / PQ), Gage R&R studies, SPC, and capability analyses.
  • Drive CAPA and SCAR investigations to closure, ensuring timely compliance.
  • Support supplier quality, including audits and vendor qualifications (occasional international travel).
  • Collaborate cross-functionally to resolve nonconformances and improve process capability.
  • Present quality data and metrics to management and foster a culture of continuous improvement.

    • What We’re Looking For

  • BS in science, engineering, or manufacturing (candidates near completion considered if medical device experienced).
  • 2+ years of medical device quality engineering experience (5+ years in regulated industry preferred).
  • Strong knowledge of FDA 21 CFR Part 820, ISO 13485, and EU MDR.
  • Hands-on experience with design controls, risk management, CAPA, and process validations.
  • Applied statistics experience (SPC, DOE, GR&R, Cpk / Ppk).
  • Excellent documentation, analytical, and communication skills.

    • Preferred but not required

  • ISO 13485 Lead Auditor, ASQ CQE, or Six Sigma Green / Black Belt.
  • Experience with medical device sterilization (Gamma preferred).

    • Location & Travel

  • Onsite in Tualatin, OR ( relocation assistance available ).
  • Minimal travel (

    • 👉 Apply today through Kelly Engineering to take the next step in your Quality Engineering career. Interviews are moving quickly!

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    Quality Engineer • Tualatin, OR, United States