QC Analyst

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
• 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, RM2,800.00 per month

Benefits:

• Free parking
• Health insurance
• Maternity leave
• Opportunities for promotion
• Parental leave

Work Location: In person