Join us to make technology safer for human beings!
You want to become an outstanding expert in quality and safety or enrich your expertise. You are interested in developing your expertise functional safety and quality. You enjoy performing in an agile and international working environment where both German and English are spoken. Creating customer solutions in exciting consulting projects would give you professional satisfaction.
Contact us now, if you want to be in our team!
To expand our team of experts we are looking for an Automotive Functional Safety Expert.
Join our FSQ Experts team, if you…
- you want to enrich your outstanding experience as an automotive functional safety expert.
- it gives you professional satisfaction to empower customer teams through specialist coaching so that they can develop and get approved safety critical products (on System- / HW- / SW-level).
- you are keen to actively support the development of ADAS and Automated Driving solutions with consultancy and engineering.
- you are interested in deepening and applying your technical and process expertise in the field of functional safety at the interfaces to security and related systems engineering topics, such as SOTIF or ASPICE.
Read more about this position here.
- hold an excellent degree in engineering or another relevant field and have more than 5 years first-hand work experience in consultancy for RA & QM for Medical Devices.
- have regulatory experience with all classes of devices.
- have experience with FDA, Health Canada, NMPA.
- have strong knowledge of MDD/ MDR and IVD/ IVDR.
- provide regulatory input to new product developments and product lifecycle planning for our customers.
- actively support the development of multi-country regulatory strategies for medical devices
- support and review regulatory submissions to authorities.
- experience working with other medical standards (e.g. ISO 13485, ISO 14971) would be a bonus.
- hold an excellent degree in engineering or another relevant field and have more than 5 years first-hand work experience within technical development of medical device systems.
- have a strong knowledge of systems engineering and standards across the EC 60601-x series, as well as IEC 62304
- have experience in a technical consulting role.
- have a good general knowledge of regulatory and quality requirements for medical devices.
- have experience supporting the development of medical devices through the whole product life cycle, from conception to market entry, and technical audits.
Do you want to join us but don’t find the right position?
Contact us anyway and let us know how you can contribute to our team.