Quality Engineer

17 hours ago

Johor Bahru, Johor, Malaysia ResMed (Malaysia) Sdn Bhd (MY) Full time $90,000 - $120,000 per year

Job Summary

The Quality Engineer plays a key role in ensuring that all products manufactured meet ResMed's quality, safety, and regulatory standards. This role is responsible for developing, implementing, and improving quality control programs and systems within a regulated medical device manufacturing environment. The Quality Engineer supports production teams, drives continuous improvement, and ensures compliance with ISO 13485, FDA regulations, and Good Manufacturing Practices (GMP).

Key Responsibilities

Quality & Compliance Support

  • Support manufacturing and Factory Focus teams to achieve key Quality, Delivery, and Cost (QDC) performance indicators.
  • Ensure manufacturing processes comply with ResMed's Quality Management System (QMS), GMP requirements, and applicable regulatory standards.
  • Lead and participate in cross-functional reviews to standardize quality practices across ResMed's global sites.
  • Monitor production processes, identify quality issues, and drive corrective and preventive actions (CAPA).

Quality Systems & Continuous Improvement

  • Develop, enhance, and maintain quality systems in support of manufacturing operations.
  • Conduct risk assessments and support implementation of risk mitigation strategies in accordance with ISO 14971.
  • Analyze data trends to identify systemic issues and recommend improvements to processes, methods, and procedures.
  • Ensure timely closure of quality events including deviations, non-conformances, and audit findings.

Technical Leadership & Collaboration

  • Provide technical guidance to internal stakeholders and global Quality Engineering teams.
  • Support audits (internal, supplier, and regulatory) and ensure readiness for inspections.
  • Build strong working relationships with cross-functional teams, suppliers, and external partners to reinforce a strong culture of quality.
  • Promote continuous education on quality and regulatory requirements to strengthen organizational understanding and compliance.

Qualifications

Required

  • Bachelor's degree in Engineering, Science, or related technical discipline.
  • 3–5 years of experience in Quality Engineering or QA roles within medical device, pharmaceutical, or other regulated manufacturing industries.
  • Strong written and verbal communication skills in English, with the ability to articulate technical concepts clearly.
  • High attention to detail with the ability to review, interpret, and analyze technical documents and data.
  • Able to work independently and collaboratively in a fast-paced environment with evolving priorities.

Preferred

  • Working knowledge of ISO 13485, FDA 21 CFR Part 820, and Good Manufacturing Practices (GMP).
  • Familiarity with medical device standards such as ISO Risk Management) and IEC 60601.
  • Hands-on experience supporting audits, CAPA processes, and quality investigations.
  • Strong analytical and problem-solving skills with proven experience driving process or system improvements.
  • Ability to lead or influence cross-site quality initiatives.

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