As a key member of our R&D department, you will serve as the pivotal link between research and quality, ensuring our cutting-edge development work aligns seamlessly with regulatory standards. This role holds significant influence, shaping the QMS within our R&D landscape. You’ll drive quality from concept through to execution, leaving your fingerprint on technologies that transform lives. 
Your responsibilities:

• Act as the central interface between the R&D department and the company-wide QA division, ensuring continuous collaboration and alignment on quality-related topics
• Establish, maintain, and continuously improve the QMS framework within the R&D environment, in alignment with ISO 13485 / Section 7.3 (Design and Development)
• Ensure ongoing compliance of Clinical Polarizer (Lean Pharma Plan/Device) development with QMS standards by actively monitoring and reviewing development activities.
• Administer the QMS tool and manage our internal standards database
• Analyze product defects, complaints, and non-conformities, initiating and tracking corrective and preventive actions (CAPA) as necessary
• Plan, organize and deliver internal training sessions on quality-related topics to promote awareness and compliance across the team
• Plan and execute internal and external audits, assist with supplier qualification and monitoring, and follow up on audit findings to drive continuous improvement.
• Lead the risk management process for the development of the Polarizer, from initial hazard identification through risk analysis, evaluation, and mitigation. Develop and maintain all related risk management documentation
• Support ongoing development activities of the Preclinical Polarizer by providing expert input on QA-related aspects as needed