QA MANAGER

Sem Matic Sdn Bhd; Johor Bahru; On-site; MYR 100,000 - 150,000; Full time

Job summary

A leading medical device manufacturer in Johor Bahru is seeking a Quality Assurance Engineer to establish and maintain the Quality Management System in compliance with regulatory standards. Responsibilities include overseeing quality inspections, leading audits, and managing nonconformities. The ideal candidate will have a degree in Engineering and 3–5 years of experience in quality engineering, preferably in the medical device sector, along with strong knowledge of relevant quality tools and practices.

Qualifications

• 3–5 years experience in quality engineering, preferably in medical device manufacturing.
• Knowledge of ISO 13485, 21 CFR Part 820 (FDA QSR), and Good Manufacturing Practices (GMP).
• Familiar with Capability analysis reports.

Responsibilities

• Establish and maintain the Quality Management System (QMS).
• Oversee the approval of incoming materials, in-process production, and finished goods.
• Lead internal and external audits and manage documentation.

Skills

Quality tools (8D reports, Ishikawa diagram, PDCA)

Capability analysis

Measurement equipment usage (caliper, micrometer)

SPC software (Minitab)

CAPA report analysis/execution

Education

Degree in Engineering (Mechanical, Manufacturing, Biomedical or related field)

Tools

Quality Management software

Job description

Establish, implement, and maintain the QMS in accordance with ISO 13485, 21 CFR Part 820, ISO 9001, IATF 16949:2016 & ISO 22000 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.

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.

Qualification Requirement:

Degree in Engineering (Mechanical, Manufacturing, Biomedical, or related field).

3–5 years experience in quality engineering, preferably in medical device manufacturing or precision machining.

Experience in IATF16949, ISO 9001, ISO14001, OHSAS18001, ISO22000.

Knowledge of ISO 13485, 21 CFR Part 820 (FDA QSR), and Good Manufacturing Practices (GMP).

Knowledge of quality tools (8D reports, Ishikawa diagram, PDCA, etc.).

Familiar with Capability analysis reports.

Capable to analyse or execute a CAPA report.

Use basic measurement equipment (caliper, micrometer, etc.).

Knowledge of SPC software (Minitab).

Knowledge of Quality Management software.

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