Medical Equipment Assistant Engineer / Engineer
Job Responsibilities:
- Prepare, maintain, and update technical files, SOPs, and MDR-related documents in accordance with company policies and regulatory requirements.
- Ensure all documentation is accurate, traceable, and audit-ready and assist with internal audits, record management, and quality improvement activities.
- Coordinate with suppliers for material requisitions and manage defect reports or returns.
- Collaborate with the QMS team to ensure adherence to internal quality processes and regulatory compliance.
- Handle production assembly, in-process inspection, and complete final testing together with the QA team.
- Provide technical support, including machine setup, evaluation, assembly, testing of automation machines/medical equipment, user training, and after-sales service.
- Perform basic mechanical and electrical assembly tasks with guidance and on-the-job training.
- Follow up promptly to ensure issues are resolved according to company standards and timelines.
Job Requirements:
- Minimum Degree in Mechanical/Mechatronics Engineering, Electrical and Electronics, Robotics or related field.
- For diploma holders, at least 5 years of relevant working experience preferred.
- Good communication, writing and coordination skills.
- Able to work independently, proactive, and willing to learn.
- Good knowledge in MS Office (Words, Excel & PowerPoint).
- Able to adapt to a fast-paced, regulated environment.
- Required to work in cleanroom environment at some times. (Need to wear cleanroom jumpsuit)