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

By bridging the gap between the physical and digital worlds, we help to accelerate digitalisation and sustainability: so that our customers around the world can become more competitive, resilient and sustainable.

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