Job Description

Overview:
The Quality Assurance Specialist is responsible to:

• Maintain and ensure effectiveness of the Quality Management System in Singapore and Malaysia,
• Perform product complaints handling for Singapore and Malaysia,
• Perform Adverse Events reporting to local regulatory authorities of Singapore and Malaysia,
• Perform Field Safety Corrective Actions and reporting for Singapore and Malaysia.

• Quality Assurance for all aspects of the Quality Management System (QMS) of Singapore and Malaysia Distribution Centre (DC), including maintenance, continued compliance, and certification.
• Ensure quality and regulatory compliance to relevant applicable standards such as GDPMDS (Singapore) and GDPMD (Malaysia).
• Be responsible for operational quality matters including product hold in Singapore and Malaysia.
• Act as the Complaints Handling unit for Singapore and Malaysia.
• Conduct training of staff in QMS to ensure relevant staff are trained to the latest revision of procedures.
• To perform assessment and adverse event reporting to local authorities of Singapore and Malaysia.
• Execute Field Safety Corrective Actions (FSCA) in Singapore and Malaysia, including reporting to local authorities.
• Manage outsourced activities to ensure vendors meet the Cook Medical's quality standards.
• Coordinate or investigate CAPA to ensure nonconformances are addressed effectively.
• Schedule and perform internal audits. Host or support external audits.
• Perform trending and produce metrics for DC performance, measuring against key performance indicators.
• Maintain up-to-date knowledge and compliance with Global policies and procedures and to implement locally.
• Participate in global projects and meetings if applicable.
• Act as the local contact person for Data Protection facilitation.
• Perform other tasks assigned by Manager.
• Ability to travel between Singapore and Malaysia.
• Have a sound understanding of, and comply with, the COOK Code of Conduct and Company Compliance requirements.

• At least 3 years working experience as quality assurance in the medical device field.
• Degree in Science, Engineering or other related discipline.
• Experience in adverse event assessment and reporting for Singapore and Malaysia.
• Experience in Field Safety Corrective Action execution and reporting for Singapore and Malaysia.
• Experience in multinational medical device company preferred.
• Excellent communication and interpersonal skills, able to work with people from different levels internally and externally.
• Excellent time management and organizational skills. Able to perform duties with limited supervision and meet deadline.
• Knowledge of Bahasa Malaysia would be an advantage as will be managing QMS of Malaysia and corresponding with local authorities.
• Fluent in English (both spoken and written).
• Skilled in document management.
• High level of computer skills including Microsoft Office.
• Multi-tasks and able to prioritize the job tasks, depending on the urgency.
• Positive attitude, be good team player and attend to details.