1. The candidate will be part of SG Diagnostics QA department and support SG Diagnostics quality management system (QMS) in accordance to ISO 13485.
2. The candidate will provide directions on quality-related matters.
Roles and Responsibilities
1. Conduct reviews and audits of QMS
2. Draft and review QMS documents
3. Monitor all operations that affect quality
4. Collect and analyze quality data
5. Monitor quality reports and statistical reviews
6. Willing to travel and conduct audit at overseas suppliers
7. Other ad hoc duties as assigned
Job Requirements
1. Qualification
· At least a Bachelor’s degree in a Science related discipline
· ISO 13485 internal auditor certification is essential
2. Work Experience and Knowledge
· 1 to 3 years of hands-on QA experience
· Experience in medical device/IVD design control, process control, change control and/or supplier management an advantage
· Good knowledge of international medical device/IVD standards (e.g. ISO 13485, 21 CFR Part 820) and ASEAN regulatory requirements
3. Soft Skills
· Creative problem-solving skills
· Excellent communication skills
· Able to work independently and in a cross functional team
· Well organized and detailed
· Good time management skills
