Quality Operations Technician – Medical Devices

Insulet; Gelang Patah; On-site; MYR 40,000 - 60,000; Full time

Job summary

A leading medical technology company in Gelang Patah is seeking a Technician for Quality Operations. This role involves performing QA Acceptance activities, conducting quality testing, and assisting the Quality Engineer to ensure compliance with standards. The ideal candidate will have a diploma in Engineering or Science, with at least 3 years of relevant experience, particularly in the medical device sector. Proficiency in both English and Malay is essential. Join us to contribute to innovative healthcare solutions!

Qualifications

• Minimum 3 years of hands-on experience in quality operations, inspection, and testing.
• Experience in test method validation and GR&R is an advantage.
• Knowledge of GLP (Good Lab Practices) is a plus.

Responsibilities

• Perform lot qualification testing of production release.
• Conduct in-process quality assurance testing and environmental monitoring.
• Assist Quality Engineers in handling CAPA, NCMR and MRB.

Skills

Hands-on experience in quality operation

Microbiology testing experience

Proficient in English and Malay

Data entry and analytical skills

Understanding of ISO13485 requirements

Education

Minimum Diploma in Engineering or Science

Tools

Microsoft Excel

Job description

A leading medical technology company in Gelang Patah is seeking a Technician for Quality Operations. This role involves performing QA Acceptance activities, conducting quality testing, and assisting the Quality Engineer to ensure compliance with standards. The ideal candidate will have a diploma in Engineering or Science, with at least 3 years of relevant experience, particularly in the medical device sector. Proficiency in both English and Malay is essential. Join us to contribute to innovative healthcare solutions!