YOUR MISSION

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

ABOUT US

NVision is a quantum biotech startup based in Ulm, Germany, with Tier 1 investors from the USA and Europe. We are just leaving stealth mode, moving from local R&D to global commercialization and expansion.
We are developing a technology that will enable MRI-based imaging of real-time metabolism in the body, with tremendous potential for research and applications in oncology, cardiology, neurology and more. Our company brings together expertise in physics, chemistry, engineering and medicine, and we are collaborating with scientists and clinicians from top medical and research centers such as Memorial Sloan Kettering in New York, MD Anderson in Texas, Technical University of Munich, Cambridge University in the UK and more.
NVision is developing fast, robust and easy-to-use hyperpolarization technology for preclinical and clinical research in our POLARIS product line. Those devices are placed close to an MRI scanner in a research or clinical environment to produce hyperpolarized contrast agents on demand in a fast, fully-automated, multi-step chemical process. Key steps of the process contain fluidic transport across multiple vessels and chemical mixing and separation processes in fully-reuseable or single-use disposable fluid paths. We develop our commercial products jointly with external design and manufacturing partners and the process development as well as the design and manufacturing of prototypes is done entirely in-house.
We offer a dynamic international working environment, with immense room for growth, that encourages personal initiative and open communication.

• 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 neede