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SaMD Quality Assurance Manager

SciProBaden-Württemberg, Germany, Germany

Vor 8 Tagen

Stellenbeschreibung

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 [email protected] to arrange a confidential conversation.