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.