Quality controller állások Németországban egyetemi végzettséggel

• Driving supplier performance improvement through root cause analysis, corrective action and supplier performance reviews;
• Ensure compliance with the European Medical Device Directive and associated regulations;

• Batch record review for API and bulk product for monoclonal antibody prefilled syringes
• Assessment and documentation of product deviations, OOS, and changes
• Quality oversight for relevant service providers, including CMO's, laboratories, technical operations and supply chain

• Set up test systems (hardware / virtualized) in complex network structures so that they are ready to perform test cases
• Set up and run tests in line with test specifications and take appropriate actions (i.e. passing the test, raising a defect)

You develop, maintain, and continuously improve the Quality Management System in accordance with ISO 13485, MDR, and other applicable regulatory requirements...

• Develop and maintain automated tests: automate when it makes sense, think about ROI, don't overengineer solutions.
• Own the testing and quality processes of the team
• Improve the development process
• Lead the QAs of the hardware development unit
• Maintain and improve the testing infrastructure

• Lead the development and consistent application of technical risk management processes (FMEA: DFMEA, SFMEA, PFMEA) across all project phases.
• Drive digitalization of risk management through tools like cloud-based FMEA platforms, dashboards, and automated tracking systems.

• Creation of the IVP (Integration & Verification Plan) for L2 and L3
• Creation of the IV verification strategy and assignment of M0C (Means of Compliance) to functional requirements (DesVerActions and ProdVerActions DOORS modules)

• 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

• Close collaboration with Scrum teams to ensure high-quality releases throughout the entire SCRUM lifecycle
• Analysis of product and business requirements and translation into clear and effective test scenarios
• Execution of manual and automated tests, including component, integration, and system testing