Quality Operations Technician

Insulet Corporation; Gelang Patah; Presencial; MYR 60.000 - 90.000; Jornada completa

Descripción de la vacante

Insulet Corporation in Gelang Patah, Johor, is seeking a Quality Operations Technician to perform QA acceptance activities, support sterile release testing, and assist the Quality Operations Engineer. You will conduct lot qualification testing and environmental monitoring, documenting results within MES/SAP and contributing to continuous improvement initiatives.

Requirements include a Diploma in Engineering or Science with 3+ years in quality operations, plus proficiency in English and Malay.

Formación

• Minimum Diploma in Engineering or Science, or combination with experience.
• At least 3 years hands-on quality operation, inspection and testing.
• ISO13485 awareness and good documentation practices.
• Proficient in English and Malay; able to document clearly.
• Familiar with MES/SAP and data entry workflows.
• Experience in microbiology testing is a plus.

Responsabilidades

• Perform QA acceptance testing and in-process quality checks.
• Support environmental monitoring and microbiology testing.
• Troubleshoot product inspection issues and escalate when needed.
• Maintain inspection records and data entry in MES/SAP systems.
• Assist improvement efforts in pre/post-sterilization testing.
• Support CAPA, NCMR and MRB processes as required.

Conocimientos

QA testing

Documentation

Analytical skills

Communication

Teamwork

Educación

Diploma in Eng/Science

Herramientas

MES/SAP

Excel

GR&R

Descripción del empleo

Quality Operations TechnicianIn order to give you better service Insulet uses Cookies. By continuing to browse the site, you are agreeing to the use of cookies in accordance with our Privacy Policy and Terms of Use. Canada Policy, EU Policy, & US Policy.### Quality Operations TechnicianApply: Field: Gelang Patah, Johor: Full time: Posted Today: End Date: December 31, 2026 (30+ days left to apply): REQ-2026-17269Job SummaryThe 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!