Job Description

Overview:
The Quality Assurance Specialist is responsible to:
1. Maintain and ensure effectiveness of the Quality Management System in Singapore and Malaysia,
2. Perform product complaints handling for Singapore and Malaysia,
3. Perform Adverse Events reporting to local regulatory authorities of Singapore and Malaysia,
4. Perform Field Safety Corrective Actions and reporting for Singapore and Malaysia.

Responsibilities:

• 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.
• 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.