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Quality Assurance Specialist
4 weeks ago
As the new QARA Specialist, you will work closely with the QA & RA Managers to develop and manage the existing QMS and work closely on the implementation and transition to an eQMS. Alongside this you will be heavily involved in CAPA & NCR processes, SOP creation, auditing and RA support.
We are looking for an experienced Quality Assurance professional with a proven background in In Vitro Diagnostics or Medical Devices. You will have strong experience in the management and/or implementation of an ISO 13485 QMS, CAPA processes and auditing.
Key Responsibilities:nDevelop and Maintain ISO 13485 QMSnSupport the implementation and transition to an eQMSnCreation and implementation of SOPsnCAPA ProcessnAuditingnSupport RA with Risk Management, Clinical Study Documents and Technical Files
Qualifications:nDegree educated in a relevant scientific or technical fieldnProven experience in the IVD or Medical Device IndustriesnProven experience in the maintenance and/or implementation of an ISO 13485 QMSnProven experience and knowledge of CAPA Process and AuditingnAuditing certification is highly advantageous
If you have the necessary skills and experience to be successful in this role, please get in touch with the team at Cure Talent today
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