Medical Device QC Inspector — Precision & Compliance

Pentamaster Corporation Berhad; Penang; Sur place; MYR 39 000 - 58 000; Plein temps

Résumé du poste

Pentamaster Corporation Berhad is seeking a dedicated QC Inspector (medical device) in Penang. The role entails conducting rigorous visual and functional inspections, dimensional checks, and meticulous documentation to ensure compliance with FDA, ISO 13485 and internal standards.

You will collaborate with production and engineering to implement corrective actions and drive continuous improvement. The ideal candidate has a high school diploma and hands-on QC experience in pharma/medical devices,

Qualifications

• High school diploma or equivalent; quality control training/engineering background preferred.
• Proven experience as a QC Inspector in medical device/pharma manufacturing.
• Strong knowledge of medical device regulations (FDA, ISO 13485) and quality mgmt standards.
• Proficiency with precision measuring instruments (calipers, micrometers, gauges, CMM).
• Skilled in statistical quality control and interpreting quality data.
• Excellent attention to detail and accuracy.
• Good communication and teamwork skills.
• Familiarity with QC software and computerised inspection systems.
• Able to work under pressure and adapt to shift work.

Responsabilités

• Perform visual and functional inspections of medical devices at various production stages.
• Conduct dimensional and tolerance checks using precision instruments.
• Document inspection results and maintain traceable QC records.
• Identify defects/non-conformities and report to relevant departments.
• Collaborate with production and engineering to address quality issues.
• Perform statistical analysis and monitor quality metrics.
• Ensure adherence to FDA, ISO and other medical device standards.
• Support internal audits and QA initiatives.
• Maintain clean and organized inspection areas and equipment.
• Attend training on new inspection procedures and equipment.

Connaissances

Visual inspection

Dimensional measurement

Statistical quality control

Documentation

Regulatory knowledge

Quality software

Attention to detail

Communication

Teamwork

Shift flexibility

Formation

High school diploma

QC training preferred

Outils

Calipers

Micrometers

Gauges

Coordinate Measuring Machine (CMM)

Description du poste

Pentamaster Corporation Berhad is seeking a dedicated QC Inspector (medical device) in Penang. The role entails conducting rigorous visual and functional inspections, dimensional checks, and meticulous documentation to ensure compliance with FDA, ISO 13485 and internal standards.

You will collaborate with production and engineering to implement corrective actions and drive continuous improvement. The ideal candidate has a high school diploma and hands-on QC experience in pharma/medical devices,