Medical Device Quality Validation Engineer

Pentamaster Corporation Berhad; Bayan Lepas; On-site; MYR 60,000 - 90,000; Full time

Job summary

Pentamaster Corporation Berhad in Penang, Bayan Lepas is seeking a Quality Engineering Engineer – Medical Device to drive quality engineering and compliance for new product introductions and lifecycle management across our manufacturing operations.

You will lead qualification, validation and calibration activities, support QMS tasks for device development and transfer, and partner with suppliers and internal teams to ensure robust processes, risk management and regulatory readiness.

Qualifications

• Associate Degree or Degree in Engineering or equivalent.
• Minimum 3 years in validations or medical device testing in regulated industry.
• Meticulous, well-organised and strong team collaboration.

Responsibilities

• Assist in qualification, validation and calibration per ISO 13485, US-FDA QSR and MDR.
• Develop validation master plan and plans for facilities, utilities, equipment and processes.
• Support QMS activities for new device development or transfer and ensure controls.
• Support DQ/IQ/OQ/PQ, TMV and CSV activities.
• Collaborate with suppliers and internal teams on process validation and risk management.
• Assist in change controls, deviations and investigations.
• Plan for validation strategies and supplier qualification.
• Re-qualify and re-validate facilities, utilities and equipment as scheduled.

Skills

Validation

Quality Engineering

Regulatory Compliance

ISO 13485

QMS

Teamwork

Education

Engineering degree

Tools

Excel

PowerPoint

Job description

Pentamaster Corporation Berhad in Penang, Bayan Lepas is seeking a Quality Engineering Engineer – Medical Device to drive quality engineering and compliance for new product introductions and lifecycle management across our manufacturing operations.

You will lead qualification, validation and calibration activities, support QMS tasks for device development and transfer, and partner with suppliers and internal teams to ensure robust processes, risk management and regulatory readiness.