Quality Assurance Specialist (Quality Control)

Support QA Team Lead in the implementation and maintenance of an effective Quality Control program. The role will also strive to achieve goal and objectives set within the department with the emphasis on quality and efficiency.

• Quality Control for all aspects of the Quality Management System (QMS) of Singapore Distribution Centre (SADC) and Singapore Domestic Site (SDS), including maintenance, continued compliance, and certification.
• Develop and maintain an effective QC program for existing and any new processes.
• Perform Goods Inspection of products at all stages required such as receiving, stock check, returns and reworks to ensure products meet the quality requirements.
• Ensure quality status is updated in system after inspection, if needed.
• Perform inspection of Packaging Materials and Raw Materials (IFU / Booklets / Labels) and engage in Supplier development.
• Perform BOM Maintenance, if required.
• Handle Stop-Ships and respond to manufacturers.
• Continuously improve system to maintain a high standard of products.
• Coordinate with Supply Chain on destruction of products designated for scrap.
• Conduct training of staff in QMS to ensure relevant staff are trained to the latest revision of procedures.

• Involve in CAPA investigation and rework inspection.
• Involve in managing product recalls
• Maintain quality records and documents.
• Prepare QC reports.
• Perform internal audits.
• Training as QA back-up.
• Support the implementation of QMS to ISO 13485 and GDPMDS standard, ensure compliance and maintain effectiveness.
• Maintain up-to-date knowledge and compliance with Global policies and procedures and to implement locally.
• Perform other tasks assigned by QA Team Lead.
• Have a sound understanding of, and comply with, the COOK Code of Conduct and Company Compliance requirements.

• At least a Diploma/Degree in QA or other business related discipline
• At least 3 years of relevant working experience in Medical Device will be advantage
• Knowledge in inspection and maintaining QC equipment and measurement system

• Able to perform quality inspection with inspection equipment and understanding of ISO 13485 and GDPMDS.
• Excellent communication & interpersonal skills, ability to work closely with people at all levels.
• Self-motivating, able to work with limit supervision.
• Well organized, good analytical and coordination skills
• Fluent verbal and written language skills in English
• Skilled in document management.
• High level of computer skills including Microsoft Office.
• Strategic thinker with excellent time management skills.