Limited Quality Consultant (m/f/diverse) for Medical Devices (MD) and In-Vitro Diagnostics Devices (IVD), Erlangen

Premier groupe européen de haute technologie, Siemens conjugue depuis toujours performance technique, innovation, qualité et fiabilité.
Nos activités centrées sur les secteurs des infrastructures et des villes, l'industrie, l'énergie et la santé, ciblent des marchés de croissance sur lesquels le Groupe nourrit l'ambition d'être leader.

Your tasks and responsibilities

• You support SHS units worldwide in improvement projects to ensure the regulatory compliance and process harmonization in all areas of the quality management systems
• In addition, you support SHS units worldwide in the implementation of new quality management requirements
• You work together with international quality management teams to find appropriate solutions for issues consistent with existing laws and regulations
• You organize and conduct worldwide trainings on quality management topics for Siemens Healthineers employees, including preparation of the training material
• Furthermore, you participate in compliance audits and support the post audit activities worldwide
• To find out more about the specific business, have a look at Products & Services.

Your qualifications and experience

• You have successfully completed a master’s degree in natural sciences or technology
• Additionally, you have several years of professional experience in the field of quality management, ideally in the field of medical devices and/or in-vitro diagnostics
• You have already gained practical experience in working with ISO 13485 or FDA Quality System Regulation as well as in participating in audits of quality management systems
• Besides you provide a solid understanding on regulatory requirements for MDs/IVDs and you are willing to familiarize yourself with quality management topics

Your attributes and skills

• You can demonstrate sound experience in MS Office programs
• Furthermore, you bring the readiness for regular, worldwide business trips (approx. 20%)
• Due to your open personality you have already gained intercultural experience and convince us with very good business fluent German and English language skills
• Just like us, you do what you say and say what you do as well as make no compromises on quality
• You have strong communication skills and enjoy working in interdisciplinary teams
• Your profile is rounded off by initiative, analysis capability and assertiveness as well as your structured and independent way of working