Quality Engineer - Medical Devices (IQ/OQ/PQ & QC)

Yoh, A Day & Zimmermann Company; Saint Paul (MN); On-site; USD 80,000 - 90,000; Full time

Benefits offered by this job

Medical, Prescription, Dental & Vision

Health Savings Account

Life & Disability Insurance

401K Retirement Savings Plan

EAP

Certification and training

Job summary

Yoh, A Day & Zimmermann Company is hiring a Quality Engineer in Saint Paul, MN to support medical device manufacturing operations. You will resolve technical quality issues, drive process improvements, and apply ISO 14971 principles to risk management and validations as needed.

The successful candidate brings hands-on IQ/OQ/PQ validation, FMEA, CAPA experience, and strong statistical analysis skills using Minitab.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or a related technical discipline.
• Minimum 3 years of quality assurance experience in a medical device or pharmaceutical manufacturing environment.
• Experience with FDA-regulated quality systems (21 CFR 820, 210, 211) and ISO 13485.
• Knowledge of process and equipment validation methods (IQ/OQ/PQ).
• Knowledge of statistical analysis and Minitab (process capability, normality, hypothesis testing, ANOVA, sampling, DOE).
• Experience supporting manufacturing quality investigations, risk assessments, CAPA, and validation activities.
• Strong technical writing skills for validation protocols, reports, and documentation.
• Ability to work independently and communicate across departments.

Responsibilities

• Plan, execute, and document process and equipment validations (IQ/OQ/PQ).
• Develop validation protocols, establish acceptance criteria, analyze results, and prepare technical reports.
• Support risk assessments, FMEA, CAPA, and quality investigations.
• Analyze manufacturing quality data using statistical methods to support decisions and improvements.
• Collaborate with manufacturing and engineering to investigate issues and implement improvements.
• Support QMS activities including complaint analysis, risk assessments, and verifications/validations.
• Monitor processes and quality metrics to ensure regulatory compliance.
• Maintain validation records and technical documentation per QMS requirements.

Skills

Quality assurance

Statistical analysis

Problem solving

Communication

Independent work

Education

Bachelor's degree in Engineering, Life Sciences, or related technical discipline

Tools

Minitab

SPC

DOE

GRR

IQ/OQ/PQ validation

TrackWise

Arena

uniPoint

Job description

Yoh, A Day & Zimmermann Company is hiring a Quality Engineer in Saint Paul, MN to support medical device manufacturing operations. You will resolve technical quality issues, drive process improvements, and apply ISO 14971 principles to risk management and validations as needed.

The successful candidate brings hands-on IQ/OQ/PQ validation, FMEA, CAPA experience, and strong statistical analysis skills using Minitab.