Job Description
One of our large Medical Device companies is seeking a Quality Validation Engineer for a large project. The Quality Validation Engineer will lead and support validation and qualification activities for heat-seal processes and related raw materials, ensuring compliant execution of IQ/OQ/PQ documentation, robust change control, and alignment with the Quality Management System (QMS).
• Author, review, and execute qualification documentation (IQ/OQ/PQ protocols and reports) for material processes, ensuring traceability to requirements and acceptance criteria.
• Lead and support implementation, qualification, and validation of new raw materials and process changes for production lines
• Support process characterization activities by preparing test strategies, data collection tools, and executed test records; compile, analyze, and summarize results to support qualification conclusions.
• Manage and support change control activities (change requests/records), in...