QA Manager

2 days ago

Ulu Tiram, Johor, Malaysia Agensi Pekerjaan Alpha Alliance Sdn Bhd Full time 96,000 - 180,000 per year

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, 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

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