Manager of software engineering állások Külföldön (minőségbiztosítás)

POSITION DESCRIPTION We are seeking an experienced and motivated professional to join our software quality assurance team. In this key role, you will help ensure compliance with IVDR, FDA 21 CFR Part 820, and cybersecurity requirements for medical device software. - Partner with development teams...

• Responsibility for the product management activities of the YpsoPump product
• Responsibility for the global roll-out of products in collaboration with the International Product Manager and the country organizations

• Planning and initiation of business cases, definition of the project scope, objectives and deliverables. This includes gathering requirements, assessing feasibility and developing a project plan that aligns with organizational goals
• Monitoring of timelines and budget

• Develop and implement global regulatory pathways for product authorizations
• Oversee preparation and submission of regulatory documents to authorities

Following up on production-related nonconformities, supporting root cause analyses, defining and monitoring corrective actions, and preparing evaluations and statistics of nonconformities...

• Responsible for processing incoming complaints in accordance with applicable process specifications
• Independent processing and assessment of complex or critical complaint cases with potentially high risk to patient safety or regulatory compliance

Prepare, support the creation and review and execute the release of all technical documentation for digital health and software products ensuring compliance with applicable standards and regulatory requirements such as IEC, IEC...

• Focus of this position is supporting our rapidly developing in Diabetes Care (active and connected devices)
• Manage the development and implementation of RA strategies
• Support and prepare product submission documents with main focus on US
• Partner with business stakeholders on different levels

• You are responsible for quality related topics like change control, deviations and/or complaints related to DS products at CMOs
• Define together with the CMO effective CAPAs and track the timely implementation

Serve as the medical device subject matter expert to both internal and external customers for product development, risk assessment, training, implementation, literature reviews, complaints, safety signals, field action, voice of the customer, and voice of the business....

• Ensuring process adherence for the pre-market procedures
• Completeness of design history files and regulatory submissions
• Regulatory and process conformance for development and maintenance projects as a member of cross-functional teams