QA Manager

1 week ago

Ulu Tiram, Malaysia Agensi Pekerjaan Alpha Alliance Sdn Bhd Full time

**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.

Pay: RM8,000.00 - RM15,000.00 per month

Application Question(s):

- Have you worked in a clean-room-controlled production environment before?

Work Location: In person

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