Process Engineer

Kanry Search; Iskandar Puteri; On-site; MYR 67,000 - 112,000; Full time

Job summary

Kanry Search in Malaysia's Iskandar Puteri region seeks an experienced Process Engineer with hands-on exposure to medical device manufacturing and regulated environments. You will design and optimize manufacturing processes to improve product quality, productivity and cost efficiency.

You will validate processes (IQ/OQ/PQ), maintain compliant documentation (PFMEA, Control Plans, Work Instructions), analyze Cp/Cpk, investigate root causes with 8D/5 Why, and collaborate with production and quality

Qualifications

• Diploma or Degree in a relevant engineering discipline.
• Hands-on experience in medical device manufacturing.
• Familiar with ISO 13485 and regulated production.
• Experience planning and executing IQ, OQ and PQ validation.
• Knowledge of Cp/Cpk analysis and process optimization.
• Strong problem-solving with 8D, 5 Why and RCA.

Responsibilities

• Design, establish and enhance manufacturing processes to improve product quality, productivity, yield, cycle time and production costs.
• Analyse process performance and carry out capability assessments, including Cp and Cpk studies, to identify opportunities for improvement.
• Plan, execute and document process validation activities covering IQ, OQ and PQ.
• Maintain validated and well-controlled manufacturing processes in accordance with ISO 13485, customer specifications and regulatory requirements.
• Work closely with production teams to troubleshoot manufacturing issues, minimise defects and resolve process-related problems.
• Investigate process failures and implement corrective actions using 8D, 5 Why and root cause analysis.
• Initiate improvements aimed at reducing scrap, production defects, equipment downtime and process variation.
• Track and enhance manufacturing performance indicators, including OEE, production yield, scrap rate and customer quality results.
• Prepare, review and update manufacturing documents such as Process Flows, PFMEA, Control Plans, Work Instructions and validation records.
• Participate in NPI, manufacturing transfers, process development, risk assessments and qualification activities.

Skills

Cp/Cpk analysis

8D problem solving

5 Why analysis

Root Cause Analysis

Process validation

Education

Diploma or Degree in Mechanical Engineering / Manufacturing Engineering / Industrial Engineering / Mechatronics / Materials Engineering

Tools

PFMEA

Control Plans

Validation documentation

IQ/OQ/PQ documentation

Job description

An established precision manufacturing company supporting the medical technology and life sciences sectors is seeking an experienced Process Engineer with hands-on exposure to medical device manufacturing and regulated production environments.

Key responsibilities

Design, establish and enhance manufacturing processes to improve product quality, productivity, yield, cycle time and production costs.

Analyse process performance and carry out capability assessments, including Cp and Cpk studies, to identify opportunities for improvement.

Plan, execute and document process validation activities covering Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ).

Maintain validated and well-controlled manufacturing processes in accordance with ISO 13485, customer specifications and applicable regulatory requirements.

Work closely with production teams to troubleshoot manufacturing issues, minimise defects and resolve process-related problems.

Investigate process failures and implement effective corrective actions using structured problem-solving methods such as 8D, 5 Why and Root Cause Analysis.

Initiate improvements aimed at reducing scrap, production defects, equipment downtime and process variation.

Track and enhance manufacturing performance indicators, including OEE, production yield, scrap rate and customer quality results.

Prepare, review and update manufacturing documents such as Process Flows, PFMEA, Control Plans, Work Instructions, Operating Instructions and validation records.

Participate in New Product Introduction (NPI), manufacturing transfers, process development, risk assessments and qualification activities.

About you

Diploma or Degree in Mechanical Engineering, Manufacturing Engineering, Industrial Engineering, Mechatronics, Materials Engineering or a related technical discipline.

Relevant experience as a Process Engineer, Manufacturing Engineer or Production Engineer within a manufacturing environment.

Hands-on experience in medical device, medical technology or life sciences manufacturing is required.

Good working knowledge of ISO 13485 and regulated manufacturing quality systems.

Practical experience in planning or executing IQ, OQ and PQ process validation activities.

Familiar with the preparation and maintenance of Process Flows, PFMEA, Control Plans, Work Instructions and validation documentation.

Knowledge of Cp/Cpk analysis, process capability improvement, yield enhancement and process optimisation.

Strong analytical and troubleshooting abilities, with practical experience using 8D, 5 Why and Root Cause Analysis.

Able to work effectively with production, quality, engineering and other cross-functional teams.