Design Quality Engineer 80 - 100 %

Design Quality Engineer 80 - 100 % (w/m/d) For more than 40 years, we have been shaping the future of mechanical ventilation. Hamilton Medical develops intelligent ventilation solutions that support medical professionals in decisive moments. Our Hamilton ventilation devices are used in intensive care units, emergency transport, and MRI environments. They help medical teams worldwide in the care of adult, pediatric, and neonatal patients. Here, your work has a real impact. Every improvement you help shape contributes to further improving the respiratory care of patients all over the world. What you can achieve: Contribute sound specialist knowledge in quality assurance, Document Control, Risk Management & Regulatory Affairs to development projects. Coordinate activities in the internal handling of non-conforming products, in particular root cause analyses, action plans, and the processing of product deviations. Coordinate activities for external complaints, in particular the performance of root cause analyses and the definition and tracking of action plans. Collaborate with suppliers on quality-relevant deviations and complaints and coordinate corresponding measures. Participate in improvement and development projects. Support the interpretation and implementation of regulatory requirements and participate in the performance of risk assessments and risk management processes. Support or accompany internal and external audits. Record, evaluate, and report quality metrics, for example using Statistical Process Control (SPC). Plan, conduct, and document training in the area of quality. What you bring with you: Scientific/technical studies (e.g., computer science, mechanical engineering, electrical engineering, materials science, physics, process engineering) or a comparable qualification. Several years of experience in the field of Design Quality, quality management, quality assurance, or in another regulated industry in compliance with regulations (21CFR Part 11 and 820, Regulation (EU) 2017/745, ISO 13485, ISO 14971, IEC 62304, ISO 62366, ISO 80601-2,). Several years of experience with international standards and regulatory requirements for medical devices, preferably in the areas of hardware, software/stand alone, consumables. Experience in working and communicating with various regulatory authorities and the corresponding relationships is an additional plus. Fluent English skills in speaking and writing, ideally good German skills. Confident appearance and leading interim teams during product development for the implementation of necessary measures. How to apply: Learn more about professional opportunities at Hamilton under Jobs | Hamilton Medical Do you share our values and do you feel at home in a collegial, innovative, and down-to-earth environment? At Hamilton, we offer not only a motivating working environment but also meaningful work and contemporary working conditions. Our "Du" culture promotes open communication and pleasant cooperation. Become part of a team in which your competencies are valued and space is created for innovative ideas. Interested? If you have any questions, please contact us by writing an e-mail (<>) and share the following details with us: Reference: JR-6012-fjm/Contact: Juli Applications by post or by e-mail unfortunately cannot be considered. jpid4569e34jm jit0731jm jiy26jm