Senior Quality Engineer – Medical Device, Onsite Leadership

Yoh Idibu; Saint Paul (MN); On-site; USD 100,000 - 120,000; Full time

Benefits offered by this job

Medical benefits

401K retirement plan

Life & disability insurance

EAP

Job summary

Yoh Life Sciences seeks a Senior Quality Engineer for a direct-hire opportunity at the St. Paul, Minnesota site.

This role serves as the primary Quality Engineering resource, providing technical leadership across manufacturing operations, process validation, investigations, risk management, and continuous improvement initiatives. The ideal candidate brings extensive experience in regulated manufacturing environments, can independently resolve complex quality challenges, and communicates

Qualifications

• 7+ years in quality engineering or QA in regulated manufacturing environments.
• Experience leading complex investigations, CAPA, nonconformances, and validation activities.
• Hands-on with IQ/OQ/PQ and process/equipment validation.

Responsibilities

• Provide independent technical guidance and quality oversight for manufacturing operations.
• Lead investigations, CAPA, nonconformances, root cause analysis, and effectiveness verification.
• Develop and review IQ/OQ/PQ validation protocols and reports; ensure regulatory compliance.

Skills

Quality engineering

Regulated manufacturing

CAPA leadership

Root cause analysis

IQ/OQ/PQ experience

Education

Bachelor's degree in Engineering

Tools

Minitab

Job description

Yoh Life Sciences seeks a Senior Quality Engineer for a direct-hire opportunity at the St. Paul, Minnesota site.

This role serves as the primary Quality Engineering resource, providing technical leadership across manufacturing operations, process validation, investigations, risk management, and continuous improvement initiatives. The ideal candidate brings extensive experience in regulated manufacturing environments, can independently resolve complex quality challenges, and communicates