Auf einen Blick
- Aufgaben: Sei der Ansprechpartner für technische Gespräche und unterstütze bei der Qualitätssicherung von digitalen Gesundheitsprodukten.
- Unternehmen: Innovatives Unternehmen im Bereich digitale Gesundheit mit einem Fokus auf Qualität und Sicherheit.
- Vorteile: Attraktives Gehalt, Weiterbildungsmöglichkeiten und ein dynamisches Arbeitsumfeld.
- Weitere Informationen: Wachstumschancen in einem sich schnell entwickelnden Sektor.
- Warum dieser Job: Gestalte die Zukunft der digitalen Gesundheit und arbeite an spannenden Projekten mit echten Auswirkungen.
- Qualifikationen: Abschluss in Informatik oder verwandtem Bereich und 7+ Jahre Erfahrung in der Medizintechnik.
Das prognostizierte Gehalt liegt zwischen 60000 - 75000 € pro Jahr.
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.
- Remediation: Oversee the manufacturer's delivery and lead any needed remediation efforts (when needed) to address updates to documentation.
- Review Manufacturer Design History Files (DHFs) and product development documentation: from the third party DHT product manufacturers
- Conduct Risk Management and computer systems validation (CSV) for products not classified as medical device, when necessary and per global standard operating procedures (SOPs)
- Ensure compliance withinternal quality standards and global standard operating procedures (SOPs) for medical devices, including sourcing, clinical investigation, risk management, and clinical performance procedures.
- Draft or support product managers, clinical scientists, or other clinical teams with drafting technical documentation or risk management plans to meet the company specific SOP, ISO standards or Health Authority Requirements.
- Support upskilling: activities and plans to train team members new to medical device development, design control, regulatory assessment and quality documentation activities.
- Experience conducting ISO
- 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
- #J-18808-Ljbffr
Quality System Engineer (Digital Health Technologies) (m/f/d) Arbeitgeber: Talentor International GmbH
Als Senior Java Entwickler:in (m/w/d) in unserem innovativen Unternehmen erwartet dich eine dynamische Arbeitsumgebung, die von einer offenen und kollaborativen Kultur geprägt ist. Wir bieten dir nicht nur die Möglichkeit, an spannenden Projekten mit modernen Technologien zu arbeiten, sondern fördern auch aktiv deine persönliche und berufliche Weiterentwicklung durch regelmäßige Schulungen und Workshops. Zudem profitierst du von flexiblen Arbeitszeiten und der Option auf Homeoffice, was dir eine ausgewogene Work-Life-Balance ermöglicht.
Kontaktdaten:
Talentor International GmbH Recruiting-Team
