Job Description:
1. Quality Management System (QMS):
● Establish, implement, and maintain the QMS in accordance with ISO 13485, 21 CFR Part 820, and other applicable regulatory requirements.
● Lead internal and external audits; manage documentation and corrective action follow-ups.
● Ensure that all processes and procedures are properly documented, controlled, and effectively implemented.
2. Quality Assurance (QA):
● Oversee the approval of incoming materials, in-process production, and finished goods.
● Review and approve process validation (IQ/OQ/PQ), change controls, and device history records (DHRs).
● Lead risk assessments (e.g., FMEA) and ensure design and process controls are in place for new and existing products.
3. Quality Control (QC):
● Supervise QC inspection teams for raw material, in-process, and final inspections.
● Ensure accurate and timely execution of sampling, testing, and measurement activities.
● Develop and validate inspection methods, control plans, and quality metrics for molding and assembly.
4. Nonconformance & CAPA Management:
● Manage product nonconformities, customer complaints, and audit findings.
● Lead root cause investigations and implement corrective and preventive actions (CAPA).
● Monitor the effectiveness of CAPA closures and drive continuous improvement.
5. Cleanroom & Regulatory Compliance:
● Ensure cleanroom environment and personnel comply with applicable GMP, gowning, hygiene, and contamination control requirements.
● Support sterilization validation, traceability, and labeling compliance for medical products.
6. Team Leadership & Training:
● Lead and mentor QA/QC staff; build competencies through training and development.
● Ensure operators and technicians are properly trained on inspection methods and quality standards.
7. Supplier Quality Management:
- Qualify and audit suppliers for compliance with material and regulatory requirements.
- Work with purchasing and engineering to address supplier-related quality issues.
8. Customer Interface:
- Handle quality-related communication with customers, including audits, NCRs, and quality agreements.
- Ensure customer-specific requirements are integrated into production and quality processes.
9. Documentation & Reporting:
- Maintain quality documentation including SOPs, work instructions, batch records, and quality reports.
- Provide regular quality performance metrics and trend analysis to top management.
Job Requirements:
● Degree or certificate in related fields.
● 6–10 years experience in quality management, with at least 5 years in medical devices.
● Strong knowledge of ISO 13485, 21 CFR Part 820, GMP.
● Experienced in QMS establishment, audits, IQ/OQ/PQ, risk assessments (FMEA).
● Hands-on with customer complaints, supplier quality, CAPA.
● Able to lead QA/QC team, training, KPIs.
● Excellent English for reporting and client interface.
Job Type: Permanent
Pay: RM10,000.00 - RM15,000.00 per month
Benefits:
- Professional development
Work Location: In person
