Support the Risk and DQA team in their activities
Consulting team doing consulting projects
Work Closely with the software engineering team to create an excellent cross-functional relationship with the different teams involved
Cross-functionally manage the quality assurance of digital projects ensuring that deadlines, project plans and quality objectives are met
Promote organizational compliance with the quality system, on QMS Software and SDLC framework
Provide quality oversight during risk, Part 11, Annex 11 and regulatory

Strong experience (5+ years) in Quality, including QMS, Design Control, Risk Management, in the area of development, production, planning / quality assurance for Software / In Vitro Diagnostics or Medical Devices
Experience in setting up and maintaining Quality Management System (QMS) related to Software products, under ISO 13485 and ISO 14971
Risk management according to ISO 14971
Advice, guidance and preparation of regulatory documentation prior to commercialization in EU
Knowledge of MDR (EU) 2017/745 and/or (EU) IVDR 2017/746 regulations
Fluent in English
Spanish is highly valued

Risk Manager – Medical Devices

Key skills