Process Engineer [Medical Device]

Overview

Process Engineer position for a leading Medical Device Manufacturing company with a legacy of over 80 years. Location options based on your current location (Selangor or Perak). This is an expansion role with an attractive remuneration package.

Responsibilities

• 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.
• Continuous Improvement: Lead Lean and Six Sigma projects (DMAIC) to reduce scrap, rework, and labor costs while improving OEE.
• Root Cause Analysis (RCA): Inv...