MFC-2410-333QA&RA SPECIALIST (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 V&V 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
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