Job Details

Documentation and Compliance:Ensure all documentation is accurate, up-to-date, and accessible to relevant personnel. Compile and create documentation in accordance with relevant regulatory requirements. Manage all post-submission Design History File (DHF) updates in collaboration with Development device teams. Support the creation and maintenance of product Design Master Records (DM - Rs) post-submission. Process Improvement:Identify and implement process improvements to enhance efficiency, quality, and safety in manufacturing operations. Conduct root cause analysis and implement corrective actions for process deviations. Collaborate with cross-functional teams to optimize production processes and reduce waste. Responble for process characterization and defining the specification(s) for the critical process parameters (CP - Ps) to be used for the device assembly process. FA - Ts/ SA - Ts:Participate in Factory Acceptance Tests (FA - Ts) and Site Acceptance Tests (SA - Ts) to en...Assembly, Engineer, Packaging, Staff, Operations, Manufacturing