Auf einen Blick
- Aufgaben: Sei der Ansprechpartner für technische Gespräche und unterstütze bei regulatorischen Anforderungen.
- Unternehmen: Flexsis, Teil der Interiman Group, bietet maßgeschneiderte Personallösungen.
- Vorteile: 12 Monate Beschäftigung mit seltenen Reisen nach San Francisco.
- Weitere Informationen: Dynamisches Umfeld mit globalen Teammitgliedern und Entwicklungsmöglichkeiten.
- Warum dieser Job: Gestalte die Zukunft der Medizintechnik und arbeite an innovativen Projekten.
- Qualifikationen: BA/BS in Informatik oder verwandtem Bereich, 7+ Jahre Erfahrung in der Medizintechnik.
Das prognostizierte Gehalt liegt zwischen 80000 - 100000 € pro Jahr.
Flexsis is a company of the Interiman Group, one of the leading providers of personnel services in Switzerland.
Thanks to our solid expertise as well as the competencies within the Interiman Group, we offer tailored solutions in personnel consulting.
- For our client
- Roche in
- Basel
, we are looking for a reliable and motivated (m/f/d).
Quality System Engineer with DHT Technical Capabilities
• Start Date
• Latest Possible Start Date
- Planned Duration of Employment: 12 months
- Extension: Rather unlikely
- Workplace: Basel
- Home Office: No home office
- Travel: Rare, 1-2 trips during the assignment to San Francisco
Responsibilities
- Serving as the single point of contact: for technical conversations with third party device manufacturers regarding design controls, risk management, and agreements.
Act as the Subject Matter Expert (SME) on device requirements and technical nuances; also ensure these elements are appropriately integrated into study protocols and documentation.
- Compile and maintain the "Asset List" (Technical Documentation), perform technical reviews of manufacturer data, and author or review technical content for submission documents.
- Digital & Regulatory
Identity: Co-lead the regulatory characterization of DHTs with the Product Management & Design Leaders, which involves providing input into Roche’s internal Device Regulatory Assessment and supporting updates.
- Change
Control: Act as the intake point and primary assessor for changes during a study, rigorously evaluating the impact on technical accuracy, documentation, and overall study integrity.
Work will also help inform third party manufacturers of updates needed in their design control documentation.
- Evaluation: Support manufacturer qualification activities with Quality, Product Managers, Business Strategy & Operations and Procurement teams to evaluate vendor capabilities and identify technical gaps to inform viability of use as a third party manufacturer.
Must haves
- BA/BS degree in Computer Science, Software Engineering, Informatics, Biomedical, related technical field or equivalent practical experience.
Masters or advanced degree in Engineering, Quality Management, or related field.
- 7+ years’ experience in the medical device or pharmaceutical industry
- In-depth knowledge and experience executing ISO 13485, ISO 14971, IEC 62304, IEC 82304, IEC 60601-1, 21 CFR 820, 21 CFR Part 11, Annex 11, and GAMP 5, with a strong emphasis on medical device regulations and quality management systems
- Experience conducting ISO 14155 compliant clinical investigations for medical devices, ensuring regulatory and ethical standards are met
- Experience executing ISO / IEC 27001 and cybersecurity aspects related to development of medical device products
- Track record of effectively working in a matrix environment with global team members
- Fluent in English, German is of advantage
- #J-18808-Ljbffr
Quality System Engineer Arbeitgeber: FLEXSIS
Flexsis est un employeur de choix, offrant un environnement de travail dynamique et collaboratif en Suisse. Nous valorisons le développement professionnel de nos employés et proposons des opportunités de croissance au sein de notre équipe. Avec une culture d'entreprise axée sur l'autonomie et l'innovation, vous aurez la chance de contribuer significativement à notre succès tout en bénéficiant d'un cadre de travail agréable et stimulant.
