Qualifications & experience
- At least a Diploma in engineering or equivalent
- Minimum of 3 years relevant experience in QA/QC/QMS. Experience in handling audits will be considered an asset.
- Familiar with medical device standards such as ISO13485, ISO14971, ISO17025, GxP etc.
- Equipped with excellent quality management knowledge and problem solving skills such as 8D, SPC, DOE, statistics etc
- Advanced written and verbal communication and intern-personnel skills
- Able to meet schedules and work independently with minimum supervision
Tasks & responsibilities
- Manage and maintenance of the Quality Management System as per relevant standards such as ISO 13485, ISO17025, 21 CFR 820, IVDD/MDD and GxP etc.
- Conduct quality control for imaging product and imaging services to ensure the high level of compliance for products/services in all quality aspects
- Provide assistance in all internal and external audits (for example, ISO and suppliers)
- Identify, initiate and drive quality projects for continuous improvement of product/service
- Coordinates with other functions to develop business process and perform proactive risk management (risk identification, assessment, analysis and control)
- Assist in preparing and compiling dossier for regulatory submissions if required
- Other duties may be assigned as appropriate
