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)
