System Engineer JB

Our client is seeking a highly skilled and motivated System Engineer to join our team in Malaysia. As a System Engineer, you will be responsible for designing, implementing, and maintaining complex systems and solutions that support Innovexs operations and growth. The role requires an individual with strong technical expertise, problem-solving abilities, and a collaborative approach to work with cross-functional teams.

Key Responsibilities

1. Participate in the establishment, upgrading, maintenance, and daily implementation of specific modules within the companys quality management system.

2. Develop, maintain, and continuously improve the Quality Management System (QMS) in compliance with FDA regulations and standards.

3. Draft, revise, and regularly review QMS-related documentation and coordinate both internal and external communication.

4. Generate regular reports on the performance and operation of the quality management system.

5. Perform other tasks assigned by management.

Requirements

1. Bachelors degree or above, with at least 4 years of experience in sterile medical consumables; experience in the endoscopy field is preferred.

2. In-depth knowledge of ISO 13485, GMP, MDD standards, and relevant regulatory requirements.

3. Certified internal auditor with proven experience independently managing at least two full product lifecycle projects from R&D to production.

4. Strong communication, learning, and teamwork abilities with good stress management skills.