Compliance Test Engineer
Found in: beBee S CN - 1 week ago
Your role:
- Responsible for verification of full systems product release/life cycle management to ensure quality and compliance.
- Create test protocol based on the product requirement specifications and design verification plan, execute the tests and provide the test reports accordingly.
- Design and develop the appropriate test jigs and fixtures in cooperation with the cross functional teams according to the test requirements.
- Technically support to third party testing laboratories in regulatory certification process to ensure the tests are done correctly according to the product requirement specifications.
- Ensuring full Product Safety Risk Management in a regulation compliant manner.
- Responsible for laboratory capability implementation from technical aspects such as standardization of test setup, test protocol and methodology, etc. to support the achievement of accreditation from CNAS, SGS, TUV etc.
- Responsible for evaluation, development and validation of required test equipment & setup, support in calibration and maintenance work to meet the requirements of Lab QMS.
You're the right fit if:
- Bachelorâs degree or above
- Has more than 3 yrs. working experience in medical equipment/Device standard compliance testing in the Laboratory is required.
- Familiar with IEC60601 is required, experience with patient monitor related medical particular standards is preferred.
- Good communication skills in English and Chinese language
- Capable of designing and developing the appropriate test setups, fixtures and jigs to meet the purpose of requested testing.
- Calibration, Maintenance and Continuous Improvement of test system and equipment in the Laboratory
- Working together within the team for maintenance and continuous improvement of the quality management system in the Laboratory
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