Medical Device QC Technician ISO 13485

B. Braun Medical Industries Sdn. Bhd.; Penang; On-site; MYR 40,000 - 54,000; Full time

Job summary

B. Braun Medical Industries Sdn Bhd in Penang seeks a Diploma-qualified QA Inspector to check and test materials, inspect processes, and ensure finished goods meet specifications.

Candidates should have 1-2 years in the medical industry, knowledge of ISO 13485, and FDA 21 CFR Part 820 compliance. The role emphasizes equipment maintenance and accurate reporting in a manufacturing setting.

Qualifications

• Diploma with basic working experience.
• At least 1-2 years of working experience in the medical industry.
• Knowledge of ISO 13485.
• FDA 21 CFR Part 820.

Responsibilities

• Check, test, and inspect raw materials, goods in process, and finished goods.
• Compare physical characteristics to technical specifications to identify defects.
• Conduct simple tests (electrical function, reliability, packaging quality), record results and prepare simple technical reports.
• Maintain test equipment functionality, preventive maintenance, troubleshooting and calibration coordination.

Skills

Quality inspection

Testing

Documentation

Calibration

Education

Diploma

Tools

Test equipment handling

Job description

B. Braun Medical Industries Sdn Bhd in Penang seeks a Diploma-qualified QA Inspector to check and test materials, inspect processes, and ensure finished goods meet specifications.

Candidates should have 1-2 years in the medical industry, knowledge of ISO 13485, and FDA 21 CFR Part 820 compliance. The role emphasizes equipment maintenance and accurate reporting in a manufacturing setting.