Job Description
Job Summary:
The Process Validation Engineer supports medical device manufacturing by developing, executing, and maintaining validated manufacturing and test processes.
The role ensures compliance with FDA QSR ( CFR ), ISO , and cGMP requirements while collaborating cross-functionally to improve process capability, quality, and efficiency across a variety of manufacturing operations.
Roles & Responsibilities:
Develop and execute process validation strategies, including process characterization and creation of IQ, OQ, and PQ protocols and reports.
Perform equipment IQ/OQ, process OQ/PQ, test method validation, and Gage R&R studies.
Ensure regulatory compliance with FDA QSR, ISO , and internal quality system requirements; participate in audits as needed.
Compile, analyze, and interpret validation and SPC data; identify trends and opportunities for continuous improvement....