Job Description
Validation Engineer
Job Description
The Validation Engineer ensures medical manufacturing equipment and processes comply with stringent FDA regulations and cGMP standards. You'll design protocols, analyze data, and perform studies to guarantee that breakthrough medical devices are safe and manufactured to the highest quality. The position provides technical and project leadership for validation and quality initiatives, with a strong focus on validating quality control (QC) equipment and supporting design controls, risk management, and continuous improvement.
Responsibilities
+ Create, review, and approve protocols, process validations, and product validations, including IQ/OQ/PQ activities for QC equipment.
+ Provide quality engineering project leadership for new product development and the transfer of products into manufacturing.
+ Provide technical quality engineering leadership to identify, troubleshoot, and resolve quality issues across products ...
Job Description
The Validation Engineer ensures medical manufacturing equipment and processes comply with stringent FDA regulations and cGMP standards. You'll design protocols, analyze data, and perform studies to guarantee that breakthrough medical devices are safe and manufactured to the highest quality. The position provides technical and project leadership for validation and quality initiatives, with a strong focus on validating quality control (QC) equipment and supporting design controls, risk management, and continuous improvement.
Responsibilities
+ Create, review, and approve protocols, process validations, and product validations, including IQ/OQ/PQ activities for QC equipment.
+ Provide quality engineering project leadership for new product development and the transfer of products into manufacturing.
+ Provide technical quality engineering leadership to identify, troubleshoot, and resolve quality issues across products ...
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