How can you contribute to the FSQ Experts team?
You enjoy performing in an international working environment where both German and English are spoken. In your daily work, you
- actively support the development of medical devices with consultancy and engineering (e.g. Requirements Engineering, Verification & Validation, Usability).
- empower our customers to establish processes for compliance and certification.
- support gap analyses and reviews for normative requirements, best practices and industry standards.
- apply your technical skills and your soft skills to consult, coach and moderate different tasks (e.g. Risk Analysis, FMEA, Post Market Surveillance Activities).
You in our Team
- You have an exceptionally good bachelor or master’s degree in (Bio-) Medical Engineering, Medical Computing or comparable studies.
- Ideally during your studies, you had already contact with medical device regulations.
- Preferably you have experience in software and/or hardware development.
- You are willing to work in a team and motivated to be trained on-the-job to become an expert.
- You want to deepen your technical understanding about medical products as well as compliance aspects.
- You are curious about how medical devices can be developed effectively and efficiently to be safe and to the benefit of patients.
- You enjoy traveling time to time.
FSQ as your new workplace
You would like to work with us in Munich. You can expect 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.
- flexible working hours.
- a permanent contract.
English - German
Vergütung: 45.000-50.000 Eur.
Anzahl der Plätze: 1
Angaben zum Unternehmen
At FSQ Experts GmbH, we support medical devices manufacturers by raising the quality of development processes and by enhancing the know-how of project teams towards a level of sustainable MDR and FDA compliance. We work with a network of partners and place very high demands upon ourselves with regard to technical competence and customer satisfaction.
FSQ Experts' Principles:
1. Analysis of customer‘s product, process and team competences
a) never subjectively, never finger-pointing, but always explaining objective, historical and technical root causes
b) truthful, real project situation presented unadorned
c) solution oriented, showing how to overcome deficiencies.
2. Strategy: designed not just to get the customer through the assessment somehow, but to raise the quality of development / management processes and the know-how of staff members to the level of sustainable compliance.
3. Goal: enabling the customer‘s team to walk alone!
All services and recommendations shall be specifically designed to achieve this goal!
Technische, physikalische und chemische Untersuchung