Process Technician

13 hours ago

Butterworth, Penang, Malaysia Knowles Electronics (M) Sdn. Bhd. Full time $40,000 - $70,000 per year
Summary Description

Responsible for sustaining stamping process and other value-added processes (such as plating & annealing process, etc) by assisting engineer to meet quality, safety, and regulatory standards (FDA, ISO 13485, GMP) while improving production efficiency, yield, and cost. Drives continuous improvement initiatives and supports new product.

Main Role : Executes, monitors, and troubleshoots processes on the production floor.

Focus : Process operation, equipment setup, maintenance, daily support.

Key Tasks : Inspect products, run tests, support validation execution, record data.

Regulatory Responsibility : Follows procedures; supports documentation.

Technical Skills : Equipment operation, basic process troubleshooting, measurement tools

Interaction : Works mainly with operators, engineers, and supervisors.

Decision Level : Executes instructions and reports issues; supports improvements.

Output : Stable daily production and accurate records.introduction (NPI) activities. Knowledge of ISO 13485 requirements is an added advantage.

Specific Duties And Responsibilities

1. Process Support

  • Monitor and control manufacturing process.
  • Assist in daily troubleshooting to resolve minor production issues.
  • Support engineers in maintaining stable production yield.
  • Prepare clear WI for operation to follow

2. Quality & Inspection

  • Conduct in-process inspection monitoring
  • Report non-conformities and support containment actions.

3. Validation Support

  • Assist in executing IQ/OQ/PQ validation activities.
  • Data collecting for production set up and collect validation samples as per protocol.
  • Document results and escalate deviations to engineers.

4. Process Monitoring Compliance

  • Ensure process is operating within defined parameters.
  • Support preventive maintenance development activities.
  • Follow process protocols and safety rules.
  • Maintain 5S and good housekeeping in the production area.
  • Comply with ISO 13485 and company SOPs.

5. Perform any other tasks as assigned by the superior.

Position Requirement

Education      : Diploma / Certificate in engineering, technical school, or equivalent experience.

Experience    :  Minimum 2 years in metal stamping or precision manufacturing environment.

Skill

· Basic knowledge of stamping processes and tooling. Able to read work instructions and engineering drawings.

· Basic understanding of ISO 13485 operation requirements

· Experience with medical device manufacturing (metal stamping, packaging, passivation/sterilization, annealing).

·  Good documentation habits and attention to detail.

Special Requirement: Hands-on experience in process troubleshooting and improvement. Knowledge of ISO 13485 is an added advantage.

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