Quality Operations Technician
On-siteGelang Patah, Johor, Malaysia
Job Summary
Conduct preventive maintenance and calibration of QA equipment, coordinate environmental monitoring and microbiology testing, and perform lot qualification testing for production release. Execute in-process quality assurance testing, troubleshoot product inspection issues, and maintain inspection records within SAP or MES systems. Develop test programs for QA equipment, participate in validation activities, and track qualification test data to provide feedback to the Quality Engineer. Generate weekly, monthly, and quarterly data analysis reports while assisting with CAPA, NCMR, and MRB processes. Participate in internal or external quality audits and conduct training on equipment usage and quality measures.
Required Qualifications
- 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
- Reasonable understanding of ISO13485 requirements
- Experience in GDP (Good Documentation Practices) & legible handwriting
- 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
Desired Qualifications
- Microbiology testing experience
- Experience in test method validation and GR&R
- Knowledge of GLP (Good Lab Practices)
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