Risk Management: Support maintenance of the risk register, coordinate risk reporting submissions, and assist in preparing materials for Risk Review meetings and committee reporting.
Accreditation & Audits: Coordinate accreditation activities, track compliance with regulatory standards, and monitor progress of corrective action plans.
Quality Improvement: Support patient safety and quality initiatives, including reporting, awareness activities, and monitoring of improvement metrics.
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Develop Validation SOPs, templates, guidelines, Validation Protocols and Reports including supporting site discrepancies and deviations investigation / closure in line with corporate policies and standards
Provide guidance and direction on all validation activities at the Singapore site
Ensure that all validation activities with respect to process, cleaning, facilities/equipment and computerized system stated in validation plan/ protocol are carried out in accordance with relevant policies, standards, procedures and guidelines, and completed in a timely fashion
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Manage and drive RMA processes including failure analysis, root cause investigation, and corrective/preventive actions (CAPA) to ensure timely resolution of customer returns and minimize recurrence.
Perform detailed failure analysis on semiconductor components, assemblies, and systems using appropriate tools and methodologies, collaborating closely with design, process, and test engineering teams.
Lead quality improvement initiatives by analyzing RMA trends, identifying systemic issues, and implementing continuous improvement actions aligned with semiconductor industry standards (e.g., IPC, JEDEC).
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