MFC-2410-333SENIOR QUALITY TECHNICIAN (TEMPORARY)MADRID Quality Assurance- Requirements: Participate in conjunction with the Head of QA and VP Regulatory and Clinical Affairs in the implementation of a total quality culture in the company, ensuring full company compliance with MDR, ISO 13485 and 9001 requirements, and internal quality manuals, procedures and instructions.
Maintenance and Improvement of QMS including SOP and WI development.
Lead General Regulatory Audits and Approval Submissions.
Drive internal and supplier audits Coordinate and manage Management Meeting Review, including the maintenance of the QA metrics (KPIs) Management and monitoring of non-conformities and CAPAs Management of QMS SW validations Management, design and performance of QA training Support in the management of budget of the Quality department Support the Engineering and Manufacturing department in Quality and Regulatory Aspects of operations management – Management of DCOs (Document Change Orders) Management of suppliers' evaluation Regulatory Assurance – Requirements: Maintenance of Regulatory Environment Participate in the preliminary work for FDA, CE and other medical approval processes in collaboration with agents, approval bodies and consultants/CROs.
Participate in the documentation for regulatory approval bodies and consultants Coordinate Risk Assessment and Analysis throughout QMS and Product Development/Manufacturing Support VV activities Support Clinical Investigations Submission to NCA and ECs Specific competencies required: Experience in the HealthCare Sector (3/5years) Trainee experience in Quality Assurance, Quality Control, Thorough knowledge of ISO 13485:2016, ISO 9001:2015, and relevant Medical ISO standards, MDR, along US-FDA Regulations.
Knowledge in GMP, GLP, GDP Education and experience Industrial Engineering, Science or Medical Device Technology Degree English (ALTE-4 or higher) Prior experience in the medical device industry Certified Quality Auditor (preferably) Reporting line: Head of QA and VP Regulatory and Clinical Affairs #J-18808-Ljbffr