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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!

OPEN POSITIONS

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.

To expand our team of experts we are looking for a Regulatory Affair Consultant. Join our FSQ Experts team, if you…
  • 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.
  • have experience working with other medical standards (e.g. ISO 13485, ISO 14971).
  • are fluent in German and English (C1 level) or are currently studying to achieve this level.
You are most welcome in our FSQ Team if you…
  • have alignment with the company’s mission and work well in a team environment.
  • have the ability to work autonomously with a positive mind set.
  • are self-organized and self-motivated.
  • are communicative and service oriented, willing to support and empower a wide variety of clients from small start-ups to large multi-nationals, able to adapt to different company cultures and situations.
  • are pragmatic, enjoy a mix of activities in regulatory affairs, quality assurance, clinical affairs, technology and business processes.
  • are willing to train team members on-the-job to become RA experts.
  • are an effective team builder and problem solver, exhibiting a collaborative management style and the ability to bring out the best in people through example.
  • want to empower our customers to establish processes for compliance and certification by assisting in the development and improvement of Quality/Regulatory processes.
  • enjoy traveling from time to time and being involved in customer projects in Germany, Europe, and world-wide.
Read more about this position here.

To expand our team of experts we are looking for a Technical Consultant.

Join our FSQ Experts team, if you…
  • 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.
  • are fluent in German and English (C1 level) or are currently studying to achieve this level.
You are most welcome in our FSQ Team if you…
  • have alignment with the company’s mission and work well in a team environment.
  • have ability to work autonomously with a positive mind set.
  • are self-organized and self-motivated.
  • are communicative and service oriented, willing to support and empower a wide variety of clients from small start-ups to large multi-nationals, able to adapt to different company cultures and situations.
  • are pragmatic, enjoy a mix of activities in technology, business processes, quality assurance, and coaching.
  • are willing to train team members on-the-job to become medical device experts.
  • want to empower our customers to establish processes for compliance and certification by assisting in the development and improvement of customer processes and knowledge.
  • enjoy traveling from time to time and being involved in customer projects in Germany, Europe, and world-wide.
Read more about this position here.

To support our team of experts we are looking for a student to support in the project Predictive Maintenance for Medical Devices.

You are the right one for this project if you…

  • are a student in (Bio-) Medical Engineering, Medical Computing, Computer Science or comparable studies.
  • are creative, self-organized, reliable and have exceptionally good scores.
  • are proficient in German and English.
  • have the ability to work autonomously.
  • have some experience with the lifecycle of a medical device from product conception to post- market surveillance activities, such as predictive maintenance.
  • have already some insights on medical device regulations (MDR, FDA, ISO 13485, ISO 14971)
  • are curious about how medical devices can be developed effectively and efficiently to be safe and to the benefit of patients.

You would like to work with us in Munich. You expect…

  • a respectful way of dealing with each other.
  • an open appreciative way of communicating.
  • to be part of a motivated team where we learn from each other on a daily basis.
  • a bright, agile and modern company.

Read more about this project here.

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.