ENGINEER, QUALITY (QMS)

Munivac; Johor Bahru; On-site; MYR 45,000 - 78,000; Full time

Job summary

Jora Malaysia is seeking to support the Quality Manager in establishing and maintaining an effective Quality Management System in compliance with various standards and regulatory requirements for medical devices.

Responsibilities include audits, CAPA, data review, handling customer complaints, and coordinating with suppliers and internal teams; requires Diploma or Degree in Engineering or Quality Management, with 1-3 years QA experience.

Qualifications

• Diploma or Degree in Engineering, Quality Management, or related technical discipline.
• Minimum 1-3 years of experience in Quality Assurance, Quality Control, or Quality Management System functions.
• Experience in medical devices, manufacturing, or regulated industries is an advantage.
• Familiar with ISO 9001, IATF 16949, ISO 13485, GMP standards.
• Strong problem-solving, analytical, and root cause analysis skills.
• Good written communication and interpersonal skills.

Responsibilities

• Maintain and improve Quality Management Systems.
• Monitor product and process quality to ensure compliance with specifications and customer requirements.
• Conduct internal audits and support external audits by customers, certification bodies, and regulatory agencies.
• Lead investigations, root cause analysis, corrective actions, preventive actions (CAPA), and continuous improvement activities.
• Review quality data, identify trends, and recommend improvement actions.
• Handle customer complaints and quality-related issues, including preparation of 8D/PDCA reports.
• Liaise with suppliers, customers, and internal teams on quality matters.
• Control non-conforming products and support containment activities when quality issues arise.
• Maintain quality documentation, records, procedures, work instructions, and training programs.
• Support QC Inspectors and Technicians in inspection and quality-related activities.

Skills

Quality Assurance

Auditing

CAPA

Root cause analysis

Analytical skills

Written communication

Education

Diploma/Degree in Engineering

Diploma/Degree in Quality Management

Tools

8D/PDCA reports

Job description

Jora Malaysia will close on 9th September 2026. Thank you for being with us, we are cheering you on as you continue your career journey.

Support the Quality Manager to establish and maintain an effective quality management system and processes in compliance to various quality management system standards, meeting customers as well as relevant statutory and medical device regulatory requirements.

Key responsibilities

Maintain and improve Quality Management Systems.

Monitor product and process quality to ensure compliance with specifications and customer requirements.

Conduct internal audits and support external audits by customers, certification bodies, and regulatory agencies.

Lead investigations, root cause analysis, corrective actions, preventive actions (CAPA), and continuous improvement activities.

Review quality data, identify trends, and recommend improvement actions.

Handle customer complaints and quality-related issues, including preparation of 8D/PDCA reports.

Liaise with suppliers, customers, and internal teams on quality matters.

Control non-conforming products and support containment activities when quality issues arise.

Maintain quality documentation, records, procedures, work instructions, and training programs.

Support QC Inspectors and Technicians in inspection and quality-related activities.

Qualification

Diploma or Degree in Engineering, Quality Management, or related technical discipline.

Minimum 1-3 years of experience in Quality Assurance, Quality Control, or Quality Management System functions.

Experience in medical devices, manufacturing, or regulated industries is advantage.

Familiar with relevant standards and regulations (e.g., ISO 9001, IATF 16949, ISO 13485, GMP).

Strong problem-solving, analytical, and root cause analysis skills.

Good written communication and interpersonal skills.