Quality Operations Technician

Job Summary

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.

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 escalate 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.

• 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!