JOB RESPONSIBILITIES
- Responsible to plan, prepare, execute and follow-up validation master plan.
- Experience in Validation Protocol, Installation Qualification, Operation Qualification, Performance Qualification and to release Final Validation report for all medical devices, production’s equipment and products.
- To work in a cross-functional team and independently to accomplish validation project objectives.
- Responsible to perform daily calibration and verification of instrument.
- Responsible to communicate and update the validation status to respective personnel and value stream members for mutual understanding.
- Responsible to train operation team on the functionality, procedure and limitation when handling any production equipment and tools.
- Responsible to prepare and review calibration and verification report.
- Responsible for writing validation, calibration and verification of system documents.
- Serves as technical expert for the validation and calibration / verification process and responsible to ensure compliance to ISO 13485 and AS 9100 standard requirements.
- Assist in Quality audit process.
JOB REQUIREMENTS
- Bachelor’s Degree in Engineering or related field; or 2 years of related working experience in Validation, Calibration and Quality; or equivalent combination of education and experience.
- Good understanding of ISO9001, ISO13485 and AS9100 standard requirements, Quality Management Systems, FMEA and root cause analysis.
- Good knowledge of validation, calibration and verification process.
- Good technical judgement and problem solving skills.
- Good attention to details and statistical skills.