Quality Assurance Manager
2 weeks ago
Roles and Responsibilities
- Conduct internal reviews to ensure quality management system is properly implemented and maintained.
- Review quality of all materials at SG Diagnostics site and supplier sites.
- Control and manage all qualityrelated documents
- Willing to travel and conduct audit with overseas suppliers
- Other ad hoc duties as assigned
Job Requirement
- Qualification
- At least a Bachelor's degree in a relevant field (e.g. life sciences, biological sciences, bioengineering)
- ISO 13485 lead auditor and internal audit.
- Work Experience and Knowledge
- Experience in IVD design control, process control, change control, supplier management etc
- Indepth knowledge of international IVD standards (e.g. ISO 13485, 21 CFR Part 820) and ASEAN regulatory requirements
- Soft Skills
- Creative problemsolving skills
- Excellent communication skills
- Able to work independently and in a cross functional team
- Well organized and detailed
- Good time management skills
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