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.

Position Overview:

Vita Coco’s Quality Control Specialist (APAC) will be a key member of the Technical Team. The ideal candidate will support in achieving the company’s quality performance by executing the established goals on quality management:

· Monitoring continuous improvement strategies in all aspects of Vita Coco’s Quality Management by reviewing and tracking the management of quality control data from various sources.

· Support new product launches in a technical capacity.

· Maintain the supplier network quality and food safety operations, ensuring compliance with regulatory standards (FDA/SMA) and third-party audits.

· Identify and execute quality control projects, including training and technical support, and perform regular communication with suppliers to report in non-conformances or quality issues.

Day-to-day activities include but are not limited to: Analyzing and performing production testing; Reviewing lab results received from company-owned or independent labs; Monitoring product integrity; Shelf life testing and similar testing as well as providing reports on product quality to the senior management at large; Maintaining and supporting various quality data systems.

This role requires frequent travel to Vietnam and other countries in APAC.

Principal Duties & Responsibilities:

· Working closely with the team to achieve quality efforts in APAC from supplier to market.

· Manage and liaise with internal and external audits on our supplier network.

· Partner with Operations & Technical team, and suppliers, to assist with any troubleshooting as required.

· Review all aspects of quality data and provide different reporting and project tracking as requested.

· Collect, analyze, and report on quality data, including lab results and product integrity tests.

· Drive investigations and resolve product quality complaints and compliance issues, providing on-the-ground support and conducting necessary corrective actions.

· Monitor compliance with regulatory and quality standards, participate in audits, and deliver training to suppliers on new products and quality procedures.

Qualifications & Skills:

· Bachelor's Degree in food technology and/or microbiology or a similar technical degree · Clear and effective communicator. Able to confidently converse with different stakeholders around the region.

· 2 to 5 years’ experience in quality management and/or R&D in food and beverage, with Aseptic tetra experience is a plus.

· Statistical analysis skills preferred, using various Business Analytics tools such as PowerBI, Python or similar

· Understanding of project management and various project management tools.

· Flexible to work extended hours to meet critical deadlines.

· Available for international travel within APAC region.

Key Attributes:

· A great team player and self starter

· Strong analytical skills and attention to detail.

· Articulate well and strategically linking business issues, analytical results, and goals.

· Understand the dynamics of an entrepreneurial high-growth business and effectively manages relationships.

· Being action-oriented to get things done quickly and efficiently with limited resources.

· Agile and easily adaptable in a dynamic environment.

· High level of ethics and integrity.