Jean-Louis Langhendries

Experience

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  Université Paris Descartes

  Sept 2010 - Dec 2010

  Internship

  Protein expression, purification and crystallization

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  Université libre de Bruxelles

  Sept 2011 - Jan 2016

  PhD candidate

  In vivo and in vitro characterization of the role of two small nucleolar RNAs in human ribosome biogenesis and in cancer

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  The University of Edinburgh

  Apr 2012 - May 2012

  Internship - Paul Anciaux Fellowship

  Characterization of protein binding sites on RNAs by UV cross-linking and high-throughput analysis of cDNAs

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  Fast Track Diagnostics - A Siemens Healthineers Company

  May 2016 - Jan 2019

  - Batch release of several components of PCR-based In-vitro diagnostic medical device- Handling of non-conformities and quality deviations- Review and release of product labels and IFU- Participation in internal quality audits - Development of Multiplex PCR assays under applicable IVD standards and regulations- Collaboration with external company for assay transfer to cartridge-based PCR medical device

  • QA/QC Scientist

    Aug 2017 - Jan 2019

  • Test Professional (R&D department)

    May 2016 - Aug 2017
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  Siemens Healthineers

  Jan 2019 - Jun 2021

  Quality Engineer

  - Leader of Quality Engineering team- Collaboration with other business units subject matter experts to implement and improve company's ISO 14971 compliant risk management process (including pFMEAs and dFMEAs)- Support of Product Development Teams for In vitro diagnostics medical device through design control- Review of product design documentation for accuracy and design history file for traceability to meet Design Control requirements.- Support of change control team for design and process change impact assessments- Support of Quality Manager for implementation of risk-based approach in the QMS (CAPA system, Post-market surveillance process)- Support of Design transfer and Process Validation team for risk analysis- Support for the implementation of an ISO 13485 compliant supplier quality management system (suppliers qualification, monitoring, re-evaluation, SCARS and suppliers audit)- Support Supplier's Corrective Action Responses and internal CAPA and problem management issues using quality tools and methodologies- Ensuring consistent implementation and compliance to the Siemens Healthineers Quality Systems and external regulations including ISO 13485, ISO 14971, In-Vitro Diagnostics Directive (IVDD) and In-Vitro Diagnostics Regulation (IVDR)- Provided audit support for internal and external audits.- Support, educate and encourage fellow Quality Engineering team members by sharing knowledge, discussing alternative options, and listening to their needs. Show less

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  Rotarex

  Jul 2021 - Nov 2022

  Quality Engineer

  - Ensure compliance of the product realization-related QMS with ISO 13485 and MSDAP requirements- Participate in the implementation of MDR requirements- Management of Quality Technicians- Champion projects that enhance and promote the effectiveness and efficiency of the Quality System and Product Quality- Work in close relationship with the Quality Manager on continuous improvement projects (e.g. modification of the ERP system, implementation of Quality softwares)- Support of Operations to make Quality/Compliance decisions on product during processing, manufacturing, testing and packaging- Release of Product batches- Detection, investigation, resolution and documentation of Quality issues (e.g. internal quality deviations and customer claims) and reporting of related KPIs- Establishment and monitoring of production Quality indicators- Organisation of internal Quality audits and hosting of external audits (certifying and regulatory bodies and customers)- Improvement of the risk management system and process validation procedures Show less

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  Luxembourg Institute of Health

  Nov 2022 - now

  Quality Officer