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process engineer
Sem Matic Sdn BhdMalaysia12 jam yang lalu
Penerangan pekerjaanLead IQ / OQ / PQ (Installation Qualification, Operational Qualification, Performance Qualification) activities. Ensure all molding processes comply with ISO 13485, FDA regulations, and customer-specific quality requirements. Prepare and maintain validation protocols, reports, and change control documentation. Collaborate with toolmakers and design engineers on new mold development and modifications. Support mold trials and sampling to evaluate tool performance. Identify and resolve molding issues such as flash, short shots, sink marks, voids, and contamination. Analysis tools like 5 Whys, Fishbone Diagrams, and FMEA to drive corrective actions. Implement and monitor SPC (Statistical Process Control) to maintain process control and minimize variation. Work closely with R&D, Quality Assurance, Production, and Regulatory Affairs during new product introduction (NPI). Train operators and technicians on molding procedures, process changes, and cleanroom practices. Lead or participate in Lean Manufacturing, Kaizen, or Six Sigma projects. Analyze process capability and drive initiatives to improve yield, reduce cycle time, and minimize scrap. Candidate must possess at least Bachelor's Degree in Chemical Engineering / Manufacturing At least 3 Year(s) of working experience in the related field Knowledge of ISO 13485 and other quality standard as well as safety regulatory requirements. Familiar with Capability analysis reports Capable to analyze or execute a CAPA report Knowledge of SPC software (Minitab)
Job description
1. Process Development & Optimization
- Develop, validate, and optimize plastic injection molding processes for medical device components.
- Use scientific molding principles and DOE to ensure repeatability and process robustness.
2. Validation & Regulatory Compliance
3. Tooling & Equipment Support
4. Defect Analysis & Troubleshooting
5. Documentation & Process Control
6. Cross-functional Collaboration
7. Continuous Improvement & Cost Reduction
Qualification Requirement :
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