André Langlhofer

QA Manager role for a portfolio of medical device / combination product development projects. Release batches of device constituent parts for clinical activities. Escalate quality challenges to senior management. Create development and commercial QA-oversight. Support device-platform initiatives. Coordinate a portfolio of QMS Remediation activities.

Design assurance project lead of 2 dedicated new product introduction project (contract manufacturer, customer project). Provides active design assurance guidance to contract development teams to ensure the projects follow the appropriate level of design control disciplines, procedures and applicable standards. Responsible for project quality planning, risk assessment, validation master plan, design controls, project reviews. Reports directly to project management and design assurance manager europe.

Responsible for planning (content, scope, resources), execution, documentation of HW and SW design verification and validation activities, including the coordination with engineering departments, project management and quality assurance. Responsible for documentation of verification plans and reports in compliance with QA procedures, full accountability for documentation of test cases and results. Technical leadership for assigned employees in order to run respective verification and validation activities.

Product development of an automated large scale instrument system in medical diagnostics (IVD); leads several design V&V studies involving all relevant stakeholders; leads feasibility studies; reviews requirements and design documents to ensure clarity and testability, contributes to design specification changes; supports building collaboration network between different R&D-groups and -sites; root cause analysis of systemic issues; leads trainings for internal and external customers

Product development of an automated large scale instrument system in medical diagnostics (IVD); early feasibility. Creating, maintaining, executing test methods for feasibility studies; analysing, reporting, presenting results in the areas: Temperature control of incubators, pipetting performance (dosing of fluids), assay performance, carry over of reagents and analytes (efficiency of wash processes), characteristics of photometric measurement units. Development of analysis tools (VBA, Matlab, Excel)

- conducted literature research, data extraction and data integration into the database (part time beside studies)

Molecular Biotechnology, Instrumental Analytics, Bioengineering. Thesis: 6 months R&D project on Industrial Biotechnology (Microbial Production Strain Development, Metabolic Engineering, Fluxome Analysis)

International Research Student, R&D project at "Algae R&D Centre" (Research on Algae Photosynthesis, Method Development, Instrumental Analytics, Computational Analysis)

Molecular Biotechnology, Bioinformatics, Bioprocess Engineering.