QMS Engineer

Intretech; Kulai; On-site; MYR 150,000 - 200,000; Full time

Job summary

A dynamic manufacturing company in Kulai, Malaysia, is seeking an experienced QMS Engineer to develop and maintain its Quality Management System (QMS) in compliance with ISO standards. The role involves conducting internal audits, documenting processes, and supporting continuous improvement initiatives. The ideal candidate will have a relevant bachelor's degree, at least 2 years of experience in ISO audits, and strong analytical skills. This position offers a collaborative environment with opportunities for professional growth.

Qualifications

• Bachelor’s degree in a relevant field.
• Minimum 2 years of experience in ISO audits.
• Certified Lead Auditor for ISO standards preferred.

Responsibilities

• Develop, implement, and maintain the Quality Management System.
• Conduct internal audits to ensure compliance with ISO standards.
• Generate audit reports with findings and recommendations.

Skills

ISO audit proficiency

Analytical skills

Microsoft Office proficiency

Attention to detail

Education

Bachelor’s degree in Quality Management, Engineering, or Business Administration

Tools

QMS and DMS software

Job description

QMS Engineer

The Quality Management System (QMS) Engineer is responsible for developing, implementing, and maintaining the QMS to ensure compliance with industry standards and regulations. This role works closely with cross‑functional teams to improve processes, enhance product quality, and support continuous improvement initiatives.

Key Responsibilities

• Establish, implement, and maintain the QMS in order to ensure the system is working and promote quality awareness throughout the organization.
• Assist the Assistant QMS Manager in ensuring the company’s QMS is established, implemented, and maintained in accordance with ISO9001, ISO14001, IATF16949, ISO13485, ISO27001, GMP, and USFDA compliance.
• Represent the department as a member of a cross‑functional team, collaborate with technicians, engineers, and project leaders to produce documentation based on established deadlines or milestones.
• Maintain and update documentation, records, files, and revisions for easy traceability. Document types include user manual, work instruction, guidelines, SOPs, forms, and other applicable documents.
• Lead and conduct thorough internal audits to evaluate compliance with ISO9001, ISO14001, IATF16949, ISO13485, ISO27001 standards, organizational procedures, and regulatory requirements across various departments and functions.
• Prepare detailed audit reports that outline audit findings, observations, and recommendations for corrective actions. Ensure reports are accurate, clear, and actionable for management and stakeholders.
• Monitor the implementation of corrective actions resulting from audits to verify effectiveness and compliance with ISO standards. Provide guidance and support to departments in addressing audit findings promptly.
• Participate in special audits or projects initiated by the Assistant QMS Manager. Contribute expertise and insight to support strategic quality initiatives and organizational goals.
• Review QMS documentation, including policies, procedures, and work instructions to ensure alignment with ISO standards and identify opportunities for improvement.

Job Requirements

• Bachelor’s degree in Quality Management, Engineering, Business Administration, or related field.
• Minimum of 2 years of experience in conducting ISO audits or quality management system audits in a regulated industry.
• Proven track record of identifying non‑conformities, conducting root cause analysis, and implementing effective corrective actions.
• Certified as Lead Auditor of any listed (ISO9001, ISO14001, IATF16949, ISO13485, ISO27001) or equivalent highly desirable.
• Computer knowledge and skills such as QMS and DMS.
• Excellent knowledge of Microsoft Office applications such as Excel, PowerPoint, Visio, Word, Access, etc.
• Strong analytical skills with any effort for detail.
• Integrity, professionalism, and discretion in handling sensitive information and audit findings.
• Ability to work independently and collaboratively with cross‑functional teams.