Job Description

Job Responsibilities

1. Quality Management System (QMS)

Establish, implement, and maintain QMS in compliance with ISO 13485, 21 CFR Part 820, and other applicable regulations. Lead internal and external audits, manage documentation, and follow up on corrective actions. Ensure all processes and procedures are properly documented, controlled, and implemented.

2. Quality Assurance (QA)

Approve incoming materials, in-process production, and finished goods. Review and approve validation activities (IQ/OQ/PQ), change controls, and device history records (DHRs). Conduct risk assessments (e.g., FMEA) and ensure design/process controls for products.

3. Quality Control (QC)

Supervise QC inspections for raw materials, in-process, and final products. Oversee sampling, testing, and measurement activities. Develop and validate inspection methods, control plans, and quality metrics for molding and assembly.

4. Nonconformance & CAPA Management

Handle product nonconformities, customer complaints, and audit findings. Lead root cause analysis and implement corrective and preventive actions (CAPA). Monitor CAPA effectiveness and drive continuous improvement.

5. Cleanroom & Regulatory Compliance

Ensure cleanroom compliance with GMP, gowning, hygiene, and contamination control. Support sterilization validation, traceability, and labeling requirements for medical products.

6. Team Leadership & Training

Lead and mentor QA/QC staff with training and skill development. Ensure operators and technicians are trained in inspection methods and quality standards.

7. Supplier Quality Management

Qualify and audit suppliers for compliance with material and regulatory requirements. Collaborate with purchasing and engineering to address supplier-related quality issues.

8. Customer Interface

Manage quality-related communication with customers, including audits, NCRs, and quality agreements. Integrate customer-specific requirements into production and quality processes.

9. Documentation & Reporting

Maintain quality documentation (SOPs, work instructions, batch records, reports). Provide quality performance metrics and trend analysis to management.

Job Requirements

Degree or certificate in a related field. 6-10 years of quality management experience, including at least 5 years in the medical device industry. Strong knowledge of ISO 13485, 21 CFR Part 820, and GMP. Experience in QMS setup, audits, IQ/OQ/PQ, and FMEA. Hands-on experience in customer complaints, supplier quality, and CAPA. Proven leadership in managing QA/QC teams, training, and KPIs. Excellent command of English for reporting and client communication.
Job Type: Full-time

Pay: RM8,000.00 - RM15,000.00 per month

Benefits:

Opportunities for promotion Professional development
Application Question(s):

Have you worked in a clean-room-controlled production environment before?
Work Location: In person