6643 - QMS Executive

Agensi Pekerjaan Minde Group Sdn Bhd; Ulu Tiram; On-site; MYR 90,000 - 130,000; Full time

Job summary

Agensi Pekerjaan Minde Group Sdn Bhd seeks an experienced Quality Management professional to lead QMS documentation control and drive CAPA/MRB processes in a manufacturing support facility in Johor Bahru region.

The ideal candidate holds a Diploma or Degree in Quality, Engineering with 7+ years in QMS, CAPA, or MRB, and awareness of regulatory standards (FDA, EU MDA, Malaysia MDA). Strong ISO proficiency and continuous improvement mindset are required.

Qualifications

• Experience with quality management systems.
• Familiar with CAPA processes and MRB handling.
• Knowledge of ISO standards and regulatory requirements.

Responsibilities

• Maintain and control QMS 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.

Skills

QMS

CAPA

MRB

Regulatory awareness

Education

Diploma or Degree in Quality, Engineering

Job description

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 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 Degree in Quality, Engineering.

7 years experience in QMS, CAPA, or MRB , preferably in the manufacturing industry.

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

• Strong knowledge and understanding of quality management systems and ISO standards