Job Description

Job Summary

We are looking for a responsible and detail-oriented QMS Technician to support the implementation, maintenance, and continuous improvement of the company's Quality Management System (QMS). The role involves ensuring compliance with ISO standards, GMP requirements, audit activities, corrective actions, risk management, and process control within a manufacturing environment.

Key Responsibilities QMS & Compliance

Maintain and update QMS documents, SOPs, procedures, and records Ensure compliance with ISO 13485, ISO 9001, ISO 14001, ISO 45001, and GMP requirements Monitor quality KPIs and support continuous improvement initiatives Assist in QMS awareness and training programs

Corrective & Preventive Action (CAPA)

Issue and manage ICAR/CAPA for non-conformances, audit findings, complaints, and supplier issues Track and follow up with departments for timely closure of corrective actions Support root cause analysis using tools such as 5 Whys and Fishbone Diagram Verify effectiveness of corrective and preventive actions Maintain proper CAPA records and documentation

Audits & Management Review

Assist in planning and conducting internal audits Support external audits by customers, certification bodies, and regulatory authorities Prepare audit reports and follow up on audit findings Ensure documents and records are audit-ready Compile data and reports for Management Review meetings

Risk & Process Management

Assist in risk identification, assessment, and mitigation activities Update risk assessments based on process changes, complaints, or audit results Support process validation activities (IQ/OQ/PQ) for equipment and production lines Maintain validation reports and records

Calibration & Equipment Control

Coordinate calibration and verification of measuring and monitoring equipment Ensure calibration is conducted according to schedule Maintain calibration records and equipment traceability

Others

Support cross-department quality and compliance activities Perform other duties assigned by the superior as required

Requirements

Diploma or Degree in Science, Engineering, Quality Management, or related field 1-2 years of experience in QMS, Quality Assurance, or regulatory compliance within a manufacturing environment or similar industry Fresh graduates with relevant knowledge or training are encouraged to apply Knowledge of ISO standards and GMP requirements Good documentation and organizational skills Detail-oriented, proactive, and able to work independently Proficient in Microsoft Office
Job Type: Full-time

Pay: RM2,200.00 - RM2,900.00 per month

Work Location: In person