Medical Device Qualification Engineer
4 days ago
We are seeking a qualified Medical Device Qualification Engineer to join our team at Recruit Express Pte Ltd.
Responsibilities:
- Develop and execute equipment qualification and validation plans and protocols.
- Conduct routine review of qualification and validation processes and documentation.
- Ensure timely calibration and corrective/preventive maintenance of equipment.
- Develop and maintain equipment database, including the pharmacy master equipment list, activity trackers, and equipment records and data files.
- Liaise with internal stakeholders to schedule equipment activities with minimal impact on operational activities.
- Liaise with external stakeholders to ensure timely equipment procurement and service delivery, including procurement of accessories and consumables, management of service contracts, provision of qualification, validation, calibration, and maintenance services, and troubleshooting activities.
Skills and Experience:
- Diploma or Degree in Life Sciences, Engineering, Information Systems, or Computer Systems.
- Preferably with equipment and systems commissioning, qualification, and validation experience.
- Preferably with GMP, biomedical, and/or clinical research experience.
- Able to work in a cleanroom environment, which requires special gowning procedures.
- May be required to support pharmacy activities out of office hours.
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