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.

Intern - Quality Assurances & Quality Control Administrator

ARYZTA Singapore is a multinational company, supplying buns and other baked products to QSR restaurants and other wholesale customers. We currently have a position open for an Intern - Quality Assurances & Quality Control Administrator.

Your duties will include:

1. Administer all Quality Assurances data and documents into the system
2. Assist in product evaluation and analysis of project samples to complete the projects to validate/change the process.
3. Assist with product (R&D samples) evaluation to complete shelf life evaluation and compute data (physical measurement).
4. Assist in finished products inspection to ensure the quality of finished products complies with APMEA and clients' expectation
5. Support related departments, for example, the Product Development team, with tasks/projects as assigned.
6. Input QA data and update QA reports by modifying and developing specifications.
7. Provide support with the Product Monitoring program- Moisture test, calibration, Bun Sensory Evaluation etc
8. Attend store visits, vendor audits, photo shoots etc., as necessary.
9. Assist with any other tasks/projects as assigned
10. Other ad-hoc duties assigned

Job Requirements:

· ITE/Degree/Diploma Holder Food Science & Technology Studies or equivalent

· No Working Experience Required. Students are welcome.

· Energetic individual, interpersonal skills and communication skills

· Problem Solving and People-oriented

· Well-versed with MS Office.

We are looking for a person who enjoys dealing with and working with various levels of management and external vendors.