Technician, Quality Operations

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

Insulet started in 2000 with an idea and a mission to enable our customers to enjoy simplicity, freedom and healthier lives through the use of our Omnipod® product platform. In the last two decades we have improved the lives of hundreds of thousands of patients by using innovative technology that is wearable, waterproof, and lifestyle accommodating.

We are looking for highly motivated, performance driven individuals to be a part of our expanding team. We do this by hiring amazing people guided by shared values who exceed customer expectations. Our continued success depends on it!

Job Title: Technician, Quality Operations

Department: Quality

Manager/Supervisor: Engineer, Quality Operations

Position Overview:

The Technician, Quality Operations is responsible for performing QA Acceptance activities in supporting testing, reporting of in-process, pre and post sterile release, environmental monitoring samples and assisting the Engineer, Quality Operations.

Responsibilities:

• Perform lot qualification testing of production release to maintain customer supply.
• Conduct in-process quality assurance testing, environmental monitoring and microbiology testing.
• Perform first level troubleshooting of product inspection/testing issues and elevate issues when necessary.
• Maintain inspection records and ensure data entered the computer and/or MES/SAP system.
• Assist Quality Engineer to optimize the pre and post sterilization product testing process as appropriate.
• Track and trend qualification test data (functional, packaging, etc.) and provide routine feedback to Quality Engineer.
• Participate in continuous improvement into the investigational process to yield more efficient and robust processes.
• Conduct training on usage of tester equipment and assist Quality Engineer on certification assessments for lot qualification inspectors.
• Assist Quality Engineers in handling CAPA, NCMR and MRB.
• Participate in internal or external quality audits, as required.
• Performs other duties as required.

Requirements

• Minimum Diploma in Engineering or Science, or with a combination of education and experience.
• At least 3 years of hands‑on experience in quality operation, inspection and testing, preferably in the medical device industry. Microbiology testing experience will be an advantage.
• Experience in test method validation and GR&R will be an advantage.
• Reasonable understanding of ISO13485 requirements.
• Experience in GDP (Good Documentation Practices) & legible handwriting.
• Knowledge of GLP (Good Lab Practices) will be a plus.
• Microsoft Excel, data entry and analytical skills.
• Must be proficient in both English and Malay language.
• Team player and ability to communicate effectively with supervisor and other employees.