MFC-2410-333SENIOR QUALITY TECHNICIAN (TEMPORARY)MADRIDQuality 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' evaluationRegulatory 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 V&V activities- Support Clinical Investigations Submission to NCA and ECsSpecific 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, GDPEducation 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