Quality Management Lead
hace 2 meses
.Noxtec Development, established in 2016, part of Nippon Gases, develops, manufactures and distributes high technology medical devices with an important added value for the users and patients globally.Over the years, Noxtec has developed extensive know-how in inhaled nitric oxide therapies, starting in neonatal intensive care units and then focusing on pediatric and adult patients, playing a key role during the treatment of Covid-19 patients.We are looking for a Quality Lead. The final candidate will be responsible for maintaining, updating, and continually improving the quality management system to ensure compliance with Medical Devices Regulation. This role requires a proportionate approach to the risk class and type of devices manufactured by NOXtec. The Quality Lead will oversee all aspects of NOXtec's organization related to the quality of processes, procedures, and devices. They will govern the structure, responsibilities, procedures, processes, and management resources necessary to implement the principles and actions required for compliance with the Medical Regulation.Responsibilities:Ensure the effective day-to-day operation, implementation, maintenance, and improvement of the Quality Management System and all its component processes in compliance with the relevant International Standards and accreditation requirements.Support in the management and delivery of the technical quality requirements of the internal procedures and the relevant International Standards.Undertake activities required to maintain current accreditations.Play a leading role in the promotion of a strong quality culture.Provide quality and accreditation advice, guidance, support, coaching and training to Noxtec staff.Participate in internal and external audits.Support in the maintenance of the document control platform Confluence.Job Requirements Qualifications:Bachelor's Degree related to Engineering or other technical equivalent studies.At least 2 years of experience working in Medical companies, preferably in quality management system.A good working knowledge of ISO-13485 and MD Regulation.Demonstrated proficiency both in English and Spanish. Other languages will be a plus.Strong communication skills and customer relationships.Excellent planning and organisational skills with the ability to prioritise workloads to meet objectives and deadlines.About Us Nippon Gases is one of the leading companies in the industrial and medical gases business in Europe. We service more than 150,000 customers and have a diversified involvement in broad industries such as healthcare, food, manufacturing, metallurgy, chemical products, electronics and energy. We aim to create social value through innovative gas solutions that increase industrial productivity, enhance human well-being and contribute to a more sustainable future.Making life better through gas technology
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