Job Description & Responsibilities
- Maintenance of Quality Management System ensuring compliance to internal, and international standards and regulatory requirements for medical devices.
- Develop QMS documents in line with business activity of DxD Hub.
- Ensure the overall document control system supports the QMS.
- Work with technical team to create quality document related to product design, development, and manufacturing, including product test/validation protocols, change management in compliance to applicable regulatory requirements.
- Lead auditor for internal and external audits.
- Conduct management review, ensure QMS stays current and relevant.
- Lead in root cause analysis and CAPA.
- Analyze trends inquality performance.
- Drive improvement in the quality management system.
Job Qualifications
- At least a Bachelor’s degree in Science/Engineering or relevant related field.
- Possess at least 4 years of working experience in quality assurance in medical devices; thorough working knowledge of ISO 13485:2016.
- Good working knowledge in managing QMS in a medical device environment in compliance to ISO 13485:2016.
- Competent in quality assurance methodologies.
- Working knowledge in QA processes for design, development, and manufacturing of IVD, SaMD and Integrated Medical Technologies.
- Demonstrated skills in risk management (ISO 14971).
- Knowledge in regulatory requirements for medical devices in ASEAN, USA and EU.
- Strong background in biomedical, computer or engineering sciences.
- Awareness of applicable workplace environment, health, and safety regulations.
- Possess creative skills and problem-solving skills.
- Adeptness in cultivating professional networks and build strategic partnerships.
- Good communication skills.
- Demonstrates strong leadership capabilities and an agile mindset.
The above eligibility criteria are not exhaustive. A*STAR may include additional selection criteria based on its prevailing recruitment policies. These policies may be amended from time to time without notice. We regret that only shortlisted candidates will be notified.
