Quality assurance auditor állások, munkák Németországban

• Closely engage in R&D projects towards introduction of new products or design changes as quality representative
• Proactively provide guidance to maintain and improve compliance of development projects with global and local processes
• Ensure conformity of the design process with applicable regulation

• One of your responsibilities will be to protect Boehringer Ingelheim by performing standard and strategic operational and/or IT audits.
• Moreover, you will conduct process assessments by analyzing information and interviewing colleagues.

• 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

• Identify and assess operational, financial, and regulatory risks
• Evaluate the effectiveness of internal controls across all business areas
• Execute audit plans tailored to the local DACH organisation
• Conduct comprehensive risk assessments to identify potential threats to the organisation

• Assist the Internal Audit Manager in the development of scope for audits and selection and development of appropriate audit procedures.
• Plan and execute audit and internal control testing procedures independently, while being able to team with individuals across various departments and functions.

• 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)

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....

• 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;

• 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

• Conducting Sales & Marketing Revisions in our PM subsidiaries around the world on a monthly basis
• Doing / Following up with all tasks needed after the revision in the country is complete
• Provide suggestions about ways we can improve our working methods with our subsidiaries

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

• Develop and maintain an in-depth understanding of business areas, its products, and supporting functions
• Assist in every step of an audit, including documentation, across scoping, planning, fieldwork and reporting

• 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

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

• 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