Job Description

Job Summary:

The QC Analyst will be responsible for performing routine and non-routine quality control activities, including testing, validation, and monitoring of ETO (Ethylene Oxide) sterilization processes.

Job Responsibilities:

Develop, execute, and document validation protocols (IQ, OQ, PQ) for sterilization processes. Review, analyse, and interpret test data to ensure compliance with internal specifications and regulatory standards (ISO 11135, ISO 13485). Perform routine documentation of Ethylene Oxide sterilization process, Biological Indicator (BI) preparation, report generation and issuance of Sterilization Certificate to the customer. Liaise with external laboratories for outsourced testing and maintain inventory of QC lab consumables. Support customers with technical queries Investigate and resolve non-conformances, deviations, and customer complaints related to sterilization processes. Involved in safety and chemical exposure monitoring activities. Maintain calibration and preventive maintenance schedule Participate in internal / external and customer audits and prepare necessary documentation.

Qualifications:

Bachelor's degree in Life Sciences, Microbiology, Chemistry, Biomedical Engineering, or a related field. Minimum of 1 year of experience in production or validation within the medical device industry. Familiarity with global regulatory standards (e.g., EU MDR, ISO 13485, MDSAP). Strong organizational skills with attention to detail and accuracy. Excellent communication and interpersonal skills. Proficiency in Microsoft Office Suite.

Location:

Bukit Kemuning, Shah Alam, Selangor.
Job Types: Full-time, Permanent

Pay: RM2,200.00 - RM2,800.00 per month

Benefits:

Free parking Health insurance Maternity leave Opportunities for promotion Parental leave
Work Location: In person