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We are currently looking for a Process Engineer for a leading player in the Medical Device Manufacturing Industry for their expansion. This company has a legacy of more than 80 years in the world. This position requires your urgent attention. Based in Selangor or Perak (based on where you are currently based at). Expansion role.
Job Responsibility:
Process Design & Optimization: Analyze existing production sequences to develop recommendations for changes in working methods that minimize risks, costs, and wastage while increasing yields
Validation & Compliance: Develop and execute validation protocols (IQ/OQ/PQ) and ensure all processes comply with Quality Management Systems (QMS) and GMP standards
Statistical Process Control (SPC): Implement and maintain SPC software to monitor critical process parameters in real-time, reducing defects such as holes or material inconsistencies
Continuous Improvement: Lead Lean and Six Sigma projects (DMAIC) to reduce scrap, rework, and labor costs while improving OEE
Root Cause Analysis (RCA): Investigate and eliminate sources of failure to improve product functionality and implement corrective/preventive actions (CAPA)
New Product Introduction (NPI): Partner with R&D and QA to support the ramp-up of new products, ensuring faster speed-to-market with stable yields
Documentation: Update and maintain line specifications, Poka-Yoke standard work instructions, and process control plans
Requirements:
Bachelor’s degree in Mechanical Engineering, Manufacturing Process, or a related Engineering discipline
3-5 years of experience in a regulated manufacturing environment (Medical Device,or High-Tech Electronics)