Key Responsibilities
1. Support the transition from the IVD Directive %28IVD-D%29 to the new EU IVD regulations %28IVD-R%29
2. Management of all training and new employee onboarding activities
3. Management of all equipment within QMS
4. Management of all suppliers within QMS
5. Management of Document control
6. Provide quality guidance and ensure all QA and regulatory requirements are met throughout the company.
7. Train employees on quality related processes.
8. Support manufacturing activities in-house and outsourced.
9. Create work instructions related to the QMS.
10. Support quality processes such as nonconformities, CAPA and ECO.
11. Support internal and external audits.
Qualifications
· Academic degree in the field of Engineering, Life Sciences, Quality or a related discipline %28paramedical%29 degree %28e.g. pharmacology, medical science%29 is advantage
· At least 2-3 years of QA experience in the field of Diagnostic %28IVD%29 or Medical Device %28MD%29- mandatory
· Prior experience in Software QA – advantage
· Prior experience in manufacturing QA – advantage
· Knowledge and understanding of Medical Device Regulations %28e.g. ISO 13485, IVDR%29 – mandatory
· Experience in supporting CE / ISO 13485 / FDA-QSR / CFDA Audits – advantage
· Production oriented approach to quality – strong advantage
· Excellent written and verbal communication skills in English
· Ability to multitask and work under pressure
· Strong attention to details, integrity and ethics
· Ability to work independently and as a team
· Knowledge in design control processes – advantage
