Termékellenőr állások, munkák 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;

Establish and maintain a project-specific Quality Management System (QMS) Develop and continuously improve the Quality Management Plan, including process maps and action plans Conduct quality assurance activities, including gate reviews and weakness analyses Support change management processes from...

• 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)

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

• 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

• 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.

• 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

• 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)

• 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