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...