Hassan Rafi

Experience

• 

  Radiometer

  Sept 2016 - Jan 2017

  Risk Manager - Intern

  Responsibilities:- Risk management of the product installations that keep the production lines running. In addition, to prepare a plan for risk minimization. Conceptual descriptions of concrete initiatives supplemented with resources and cost consumptionCompetencies and results:- Documentation of risk management with ISO 31000 and other standards- Evaluating risk according to hardware and software foundation

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  Region Sjælland

  Nov 2017 - Apr 2018

  Responsibilities:- Consulting the clinical staff in use of the software Sundhedsplatformen- Documentation of error and bugs in the softwareCompetencies and results:- Problem-solving of complex supporting task regarding software programs Responsibilities:- consulting the clinical staff in the healthcare sector in the use of the Sundhedsplatform (software)Competencies and results:- consultation skills- Field experience

  • IT Customer Support

    Jan 2018 - Apr 2018

  • IT-specialist

    Nov 2017 - Dec 2017
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  Ambu A/S

  Nov 2021 - Oct 2023

  Responsibilities:responsible for managing and enhancing the design-control processes, collaborating and aligning across the organization, and driving continuous improvement initiatives to maintain and mature our standards for product development.optimize design and development processes whilst ensuring efficient ways of working. Interact within both Quality Management System and general business processes. Ensuring processes are supporting efficient development of market-leading product portfolioCompetencies and Results:- Design Control Oversight: Development, implementation, and maintenance of R&D design- control processes in compliance with regulatory requirements (FDA, ISO, etc.). - Process Improvement: Identify opportunities for process improvements and lead initiatives to enhance efficiency, effectiveness, and compliance within the design control and process framework - Project support: Support the projects in following the processes and support preparation of design control documentation in innovation projects - Audit Preparation: Support internal and external audits related to R&D processes. Implement corrective and preventive actions as needed. - Cross-functional Collaboration: Work closely with stakeholders within R&D, Quality Assurance, Regulatory Affairs, and other relevant departments to align on best practices and implement regulatory requirements throughout the product lifecycle. - Training and Development: Provide guidance and training to cross-functional teams on design control processes, ensuring a thorough understanding of regulatory requirements and adherence to internal policies. - Problem solving in relation to NCRs, CAPA across R&D Show less Responsibilities:- Update and maintenance of Design Control procedures and guidelines and adherence to relevant standards- Update and maintenance of project management processes- Optimize processes with our product management specialists and PMO specialists- Support in Design Control activities globally across our departments in (Denmark, Germany, Malaysia, China, USA and Mexico)- Support in design changes and product changes- design transfer to production- Update of packaging process- Support in Non conformities, CA, PA- Aligning all R&D processes with Marketing, Procurement, Supply Chan, New Product Implementation and Project Management processesCompetencies and Results:- what is required in an audit from a process perspective- Insight of deliverables and activities required from all departments to create a medical device- Communication, training and coaching in the Design Control process, and governance- Create training and support in the Quality Management System- Manage Design Output deliverables from our CMO- Support in process changes due to upcoming dual manufacturing- Support Supply Chain in sample ordering through Enterprise Resource Planning- Working closely with System Engineers Show less

  • Innovation Process Specialist

    Nov 2022 - Oct 2023

  • Design Control Specialist

    Nov 2021 - Nov 2022
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  Hedia

  Oct 2023 - now

  QA/RA specialist