Senior Quality Engineer, Medical Devices — Onsite St. Paul

Yoh, A Day & Zimmermann Company; Saint Paul (MN); On-site; USD 100,000 - 120,000; Full time

Benefits offered by this job

Health insurance

401K retirement plan

Paid time off

Job summary

Yoh Life Sciences in St. Paul, MN is seeking a Senior Quality Engineer to lead site-level quality initiatives in a medical device manufacturing setting. You will drive investigations, CAPA, risk assessments, and process validation activities, ensuring QMS compliance and cross-functional collaboration.

The role requires hands-on expertise in IQ/OQ/PQ, statistical methods, and leadership of quality teams. This onsite position offers direct-hire stability and opportunities for advancement within

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or a related technical discipline.
• Minimum 7 years of progressive Quality Engineering or Quality Assurance experience in medical device or other regulated environments.
• Experience leading complex investigations, CAPA, nonconformance resolution, and validation activities.
• Strong knowledge of ISO 13485 and FDA QMS requirements; statistical quality tools.

Responsibilities

• Serve as a primary site-level Quality Engineering resource for manufacturing operations.
• Lead nonconformance investigations, CAPA, and risk management activities.
• Develop and review IQ/OQ/PQ validation protocols and reports.
• Apply SPC, Cp/Cpk, Gage R&R, DOE and statistical analyses.
• Mentor QC personnel and support audits and quality initiatives.

Skills

Quality engineering

CAPA investigations

Root cause analysis

IQ/OQ/PQ validation

GxP/regulatory compliance

DOE/ANOVA/ SPC

Cross-functional leadership

Statistical software (Minitab)

Education

Bachelor's degree in Engineering or Life Sciences

Tools

IQ/OQ/PQ validation tools

Job description

Yoh Life Sciences in St. Paul, MN is seeking a Senior Quality Engineer to lead site-level quality initiatives in a medical device manufacturing setting. You will drive investigations, CAPA, risk assessments, and process validation activities, ensuring QMS compliance and cross-functional collaboration.

The role requires hands-on expertise in IQ/OQ/PQ, statistical methods, and leadership of quality teams. This onsite position offers direct-hire stability and opportunities for advancement within