Quality auditor állások, munkák Németországban

• 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)

• Maintain and further develop our QMS in line with EN ISO 13485 and MDSAP
• Create, update, and improve procedures, forms, and training materials
• Plan and deliver training on procedures and regulatory requirements
• Lead and oversee CAPA initiation, processing, tracking, and review

Build and Empower: Take full ownership of the Quality Assurance team. You will be responsible for structuring the department, hiring specialists, and fostering a culture of precision and excellence from the ground up....

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 global manufacturing quality strategy, ensuring alignment with Voith Hydro's renewable energy objectives.
• Ensure quality oversight across diverse manufacturing processes, with a strong focus on turbine and generator fabrication.

• Review customer specifications and legal/statutory requirements, ensuring compliance with Voith Hydro standards and EQM guidelines.
• Prepare and issue project-specific Quality Plans and documentation (e.g., Inspection & Test Plans, QS, MGS).

• 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.

• Guiding and supporting your team by overcoming roadblocks and exceeding expectations
• Ensuring appropriate staffing for all active Simultaneous Development Teams (SDTs) in collaboration with Program Management and Quality leadership

• 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

• Assess quality on BP DeFi Wallet, creating and executing test plans performing manual and automated testing
• Actively participate throughout the whole development cycle and co-shape the scrum practices and ceremonies, and mentor a QA intern and dev colleagues on QA topics.

Providing clear direction, operational leadership, and continuous improvement for a QA team of 10–15 professionals...

Project & Process Quality Assurance: You define and implement quality assurance strategies across the entire product lifecycle - from suppliers and development to serial production....

• Architect and implement a robust test data management strategy across environments
• Develop and maintain test environment management frameworks to streamline testing workflows
• Design and integrate automated test data pipelines into existing CI/CD and DevOps processes