Location
Saint Paul
Job Type
Full-time
Posted
July 04, 2026
Job Description
Validation / Operations Quality Engineer – Medical Devices
Help bring life-changing medical technologies to market. We are seeking a Validation / Operations Quality Engineer to support manufacturing, process validation, and quality system activities in a fast-paced, FDA-regulated medical device environment. This role partners closely with Operations, Manufacturing Engineering, R&D, and Supply Chain to ensure products and processes meet the highest standards of quality, compliance, and performance.
What You'll Do
+ Lead and execute validation activities, including:
+ IQ/OQ/PQ
+ Process Validation
+ Test Method Validation (TMV)
+ Equipment Qualification
+ Software Validation support
+ Develop validation protocols, reports, and supporting documentation.
+ Support manufacturing transfers, line qualifications, and process improvements.
+ Troubleshoot manufacturing and process issues to improve quali...
Help bring life-changing medical technologies to market. We are seeking a Validation / Operations Quality Engineer to support manufacturing, process validation, and quality system activities in a fast-paced, FDA-regulated medical device environment. This role partners closely with Operations, Manufacturing Engineering, R&D, and Supply Chain to ensure products and processes meet the highest standards of quality, compliance, and performance.
What You'll Do
+ Lead and execute validation activities, including:
+ IQ/OQ/PQ
+ Process Validation
+ Test Method Validation (TMV)
+ Equipment Qualification
+ Software Validation support
+ Develop validation protocols, reports, and supporting documentation.
+ Support manufacturing transfers, line qualifications, and process improvements.
+ Troubleshoot manufacturing and process issues to improve quali...