Aik Chuan Tay Email and Phone Number

New Product Introduction (NPI) Projects for Medical Devices:-Responsible for construction and documentation of Design History File through Design Control Requirement per ISO 13485.-Performed Design of Experiment (DOE) in Design Verification Phase to validate processing parameters in production processes.-Planned and executed validation protocol and validation process for Equipment's Validation, Products Validation, Process Validation and validations activities compliance to EN/ISO and GB/YY (China) quality standards.-Drafting and prepared validated manufacturing SOP for production activities.-Trained and lead operators for production activities.-Attended and assisted QA Manager for CE Certification of medical device.-Troubleshoot and resolved technical & engineering issues via engineering statistical tools such as SPC and etc.-Applied Lean Six Sigma methodology such as DMAIC in approaching quality issues.Contract Manufacturing Project Management for Medical Devices Components:-Managed project planning and First Article development with 0% of Non-Conformance and ensure 100% of on time delivery before due.-Developed process flow, verifying processing parameters and quality inspection plan for every newly launched projects.-Responsible for scrap cost reduction project to ensure manufacturing output yield achieving 90% and above.-Co-lead Process Failure Mode and Effect Analysis (pFMEA) meeting to minimise potential production risks during manufacturing processes.-Developed Process Validation Protocol and qualified Process Validation in compliance with ISO 13485 requirement.-Performed Installation Qualification(IQ), Operational Qualification(OQ) and Performance Qualification (PQ) to conform with clients' quality requirement.-Applied statistical tools such as SPC, process capability study and etc in resolving manufacturing issues.