Quality Operations Technician

Responsibilities

• Maintain and coordinate the preventive maintenance and calibration programs for QA equipment.
• Perform lot qualification testing, in-process quality assurance testing, and environmental monitoring.
• Conduct microbiology testing and coordinate related sampling activities.
• Maintain accurate inspection records and ensure data is correctly entered into MES/SAP systems.
• Perform first-level troubleshooting of product inspection and testing issues.
• Assist Quality Engineers with CAPA, NCMR, MRB, and the optimization of sterilization testing processes.
• Track and trend qualification test data to provide routine feedback to the engineering team.
• Participate in internal and external quality audits and continuous improvement initiatives.

Requirements

• Minimum Diploma in Engineering or Science, or an equivalent combination of education and experience.
• At least 3 years of hands-on experience in quality operations, inspection, and testing.
• Proficiency in both English and Malay languages.
• Strong Microsoft Excel, data entry, and analytical skills.
• Working knowledge of Good Documentation Practices (GDP).
• Understanding of ISO13485 requirements.

Preferred Qualifications

• Experience in the medical device industry.
• Experience with microbiology testing.
• Knowledge of Good Laboratory Practices (GLP).
• Experience in test method validation and GR&R.

About the Company

Insulet Corporation is a global medical technology company dedicated to improving the lives of people with diabetes. Through our innovative Omnipod® product platform, we provide wearable, waterproof, and lifestyle-accommodating technology that enables our customers to enjoy greater simplicity and freedom.