Sponsor: Rubicon Genomics
Recording Date: 2/19/2014
Recording Time: 1 hour
20 days Annual Leave & PA coverage of S$100,000.00
Credo Biomedical is looking for a Quality Systems Manager to join our rapidly growing company. The successful applicant will
• work directly with and provide critical support to the company’s executive management team as the primary contact for operational issues.
• Primary responsibilities will include oversight, implementation, and maintenance of ISO 13485 certification.
• responsible for maintaining a proactive approach to current regulatory thinking through key regulatory and industrial relationships.
• Interpreting Data & taking corrective action to modify the Procedure / system
• Writing the documents for quality management system.
• Working in accordance with design & development processes.
Bachelor's degree in science or health science field
- Experience implementing ISO 13485 and Medical Device Quality Systems regulation
- Experience in quality systems management such as SOP, LMS, Deviation and CAPA systems.
- Solid working knowledge of regulation applicable to medical device industry (e.g., GLPs, HIPAA, 21CFR Part 11).
- Internal and External Audit experience
- Good computer literacy
- Excellent project management skills
- Excellent logic/problem solving capabilities.
- Excellent oral and written English communication skills.
Experience with medical device/IVD regulatory affairs
Professional certification in QA/QC systems
Experience with electronic quality management systems programs
Credo Biomedical is an innovative company with a mission to bring advanced diagnostics out of the laboratory to the point-of-need where it can be accessed by more individuals around the world. Founded in 2011, the company has already established an international team of multidisciplinary individuals in Singapore Science Park II and is well on the product development pathway. Credo is looking for passionate individuals to join our rapidly growing team to help propel us to the next phase of development.