process engineer [medical device].

• Based in Selangor or Perak (based on where you are currently based at)
• Expansion role
• Attractive remuneration package

the role

• 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.

the experience

• Education: Bachelor’s degree in Mechanical Engineering, Manufacturing Process, or a related Engineering discipline.

• Experience: 3-5 years of experience in a regulated manufacturing environment (Medical Device,or High-Tech Electronics).