Quality Engineer — Medical Devices, QA & CAPA

Munivac Sdn Bhd; Johor Bahru; On-site; MYR 90,000 - 130,000; Full time

Benefits offered by this job

Medical

Miscellaneous allowance

Parking

Training support

Team buiding

Appreciation Din

Job summary

Munivac Sdn Bhd invites a Quality professional to support the Quality Manager in establishing and maintaining a robust QMS across the organization. You will monitor product quality, conduct audits, drive CAPA and continuous improvement, and liaise with suppliers and customers.

The role requires a Diploma or Degree in Engineering or Quality Management with 1–3 years in QA/QMS environments, preferably in medical devices or regulated industries.

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 advantageous.
• Familiar with ISO 9001, IATF 16949, ISO 13485, GMP.

Responsibilities

• Support the Quality Manager to establish and maintain an effective QMS and processes.
• Monitor product and process quality to ensure compliance with specifications and customer requirements.
• Conduct internal audits and support external audits by customers and regulatory bodies.
• Lead CAPA activities and continuous improvement initiatives.
• Review quality data, identify trends, and recommend improvements.
• Handle customer complaints and quality-related issues, including 8D/PDCA reports.
• Coordinate with suppliers, customers, and internal teams on quality matters.
• Maintain quality documentation, records, procedures, and training programs.

Skills

Quality management

Root cause analysis

Analytical thinking

Documentation

Interpersonal skills

Education

Diploma in Engineering

Degree in Quality Management

Related technical discipline

Tools

ISO 9001 standards

IATF 16949 standards

ISO 13485 standards

GMP standards

Job description

Munivac Sdn Bhd invites a Quality professional to support the Quality Manager in establishing and maintaining a robust QMS across the organization. You will monitor product quality, conduct audits, drive CAPA and continuous improvement, and liaise with suppliers and customers.

The role requires a Diploma or Degree in Engineering or Quality Management with 1–3 years in QA/QMS environments, preferably in medical devices or regulated industries.