Med Device Quality Engineer: Validation & Process Improvement

Yoh

Saint Paul (MN)

On-site

USD 80,000 - 90,000

Full time

5 days ago

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Benefits offered by this job

Medical, Prescription, Dental & Vision

Health Savings Account (HSA)

Life & Disability Insurance

401K Retirement Savings Plan

Direct Deposit & weekly epayroll

Referral Bonus Programs

Certification and training

Job summary

Yoh is seeking a Quality Engineer for our medical device client in Saint Paul, MN. You will support manufacturing operations, lead validations (IQ/OQ/PQ) and drive improvements in a regulated environment.

You will analyze quality data with Minitab, perform risk assessments, and contribute to FMEA, CAPA, and QMS activities while collaborating across engineering and manufacturing teams. The role requires a Bachelor's in engineering or life sciences and at least 3 years in medical device quality,

Qualifications

Hands-on experience with process and equipment validation (IQ/OQ/PQ).
Experience in manufacturing quality investigations and CAPA.
Knowledge of FDA-regulated quality systems and ISO 13485.
Strong statistical analysis skills using Minitab and DOE.

Responsibilities

Plan, execute, and document process/equipment validations (IQ/OQ/PQ).
Develop validation protocols, acceptance criteria, and technical reports.
Support risk assessments, FMEA, CAPA, and quality investigations.
Analyze manufacturing quality data using statistics to drive improvements.
Collaborate with manufacturing/engineering to investigate issues and implement changes.
Support QMS activities including complaint analysis and verification/validation.