SaMD Quality Assurance Manager

vor 8 Stunden


Stuttgart, Deutschland SciPro Vollzeit

This is an exciting opportunity to join a rapidly growing digital health company based in the Baden-Württemberg region. Specializing in a minimally invasive neurostimulation product, the company is redefining the market through its innovative approach. With their product recently launched and gaining significant traction, they are now seeking a skilled Quality Manager with extensive SaMD expertise to help drive their continued success.


Responsibilities:


  • Evaluating the effectiveness of the QM system (management review, quality objectives)
  • Processing of complaints, corrective and preventive measures
  • Support internal, external and supplier audits
  • Quality assurance / quality control of product development processes (focus on development / software life cycle processes)
  • Risk management
  • Monitoring products on the market (post market surveillance)
  • Evaluation of regulatory changes
  • Maintaining and improving the established quality management system in accordance with the requirements of ISO 13485, MPDG and MDR 2017/745/EU


Requirements:


  • BSc in a scientific field
  • 5 or more years of experience in the medical device industry (preferably active (implantable) medical devices or software for medical devices)
  • Basic knowledge of medical device approval processes (EU/FDA)
  • Good knowledge of standards and regulatory requirements ISO 13485, ISO 14971, ISO 62304 and IEC 81001-5-1
  • Knowledge of MDR, MPDG and 21CFR820 desirable
  • Understanding of change management and transformation
  • Fluent English (German would be a plus)


Scipro is acting on behalf of this company. Please apply now or send your CV to l.cleland@sciproglobal.com to arrange a confidential conversation.



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