Quality Assurance Specialist

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.

**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.

Qualifications:

- 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.