Experience

The Univac Group

• Medical Equipment Manufacturing
• 1 - 100 Employee

• Staff Process Engineer

  • May 2021 - Present

  Jan 2022 - Validation and Pre-Production Activities are completed, currently in the production phase Production Phase - Activities but not limited to ● ISO13485 - Training as well as internal Audit ● Production / Sterilization Planning ● Providing advise to other Dept. related to production needs ● Operation Training - Training Operators / Technician on the Latest processes ● Production Processes Improvements - Work instruction , Forms ● Machine / Processes Improvements ● Communication with Clients / Supplier / Manufacturer - to meet requirements ● QMS Workgroup _____________________________________________________ After the 1st 6 month, i taken on the role of Process Engineer (Lead) responsible for evaluating Automated Assembly Machine processes for validation of Class II Medical Device assembling processes and Pre-Production Processes. Validation - Activities but not limited to ● Factory Acceptance Test (FAT) / Site Acceptance Test (SAT) - Executing with manufacture / supplier ● Process Failure Mode Equipment Analysis (PFMEA) - Creating and updating ● Master Validation Plan (MVP) - Updating latest Validation. ● Installation/Operational/Performance Qualification (IOPQ) Validation - Creating and Executing of IOPQ ● Design of Experiments (DoE) - Creating and Executing DoE ● Gage Repeatability and Reproducibility (GR&R) - Creating and Executing GR&R ● Risk Management Plan (RMP) , Risk Management Report (RMR) - managing RMP and RMR conjunction with PFMEA ● Lot / Device History Records (LHR / DHR) - Compiling and Reviewing of Records ● Medical Device File (MDF) - Ensure Latest Revision of all the Processes used per Batch / Lot ● Communication with Clients / Supplier / Manufacturer Pre-Production - Activities but not limited to ● Creating Standard Operating Procedures (SOP) ● Creating Work Instruction (WI) ● Creating Forms / Checklist for Operational use ● Creating Preventive Maintenance Work Instruction ● Communication with Clients / Supplier / Manufacturer