6643 - QMS Executive

Company Overview :

The company provides product design, engineering, and manufacturing services, supporting industries such as medical, industrial, and smart technologies. Its Johor Bahru facility offers engineering expertise, production, and supply chain support, helping clients deliver high-quality products efficiently to regional and global markets.

Key Responsibilities

• Maintain and control QMS / EMS documentation, ensuring compliance with ISO13485 / ISO9001 / ISO14001.

Plan, conduct, and support internal and external audits.

Coordinate CAPA system : investigations, root cause analysis, and closure.

Coordinate MRB : manage nonconforming materials and actions.

Support Management Reviews, reporting, KPIs, and supplier quality activities.

Conduct training on QMS / EMS / GDP and support sustainability / continuous improvement.

Ensure compliance with health, safety, and environmental policies.

Requirement :

Diploma or higher in Quality, Engineering, Environmental Science, or related field.

2 years experience in QMS / EMS, CAPA, or MRB (manufacturing / medical devices preferred).

Awareness of regulatory standards (FDA, EU MDA, Malaysia MDA) is an advantage.

Supplier quality and audit experience desirable.