Process Improvement Specialist Job Description
We are seeking a skilled Process Improvement Specialist to support our remediation initiative in the medical device industry. This contract role offers the opportunity to work directly on production line processes, ensuring compliance, robustness, and efficiency across a wide variety of products.
Main Responsibilities:
* Review and assess manufacturing processes with a focus on risk assessment and process validation.
* Develop, review, and approve validation protocols, process characterization reports, Repeat Action Assessments, and Acceptance Equipment Lists.
* Update and maintain Manufacturing Instructions and MES documents.
* Support Device Master Record remediation activities, including ownership of nonconformities and corrective actions as needed.
* Ensure all remediation activities are delivered within defined timelines.