Jean-Louis Langhendries Email & Phone Number

Dudelange, Luxembourg, Luxembourg

Luxembourg

- 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

Esch-Sur-Alzette, Luxembourg

- 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.

Luxembourg

- 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

Luxembourg

- Development of Multiplex PCR assays under applicable IVD standards and regulations- Collaboration with external company for assay transfer to cartridge-based PCR medical device

Belgique

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

Edinburgh, Royaume-Uni

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

Région De Paris, France

Protein expression, purification and crystallization

Doctor Of Philosophy (Ph.D.), Molecular Biology

Genesis Training, Biotechnology

Four days training focusing on filling the gap between the Ph.D. and the expectations of health care companies

Introduction To Gmp And Glp

Statistical Analysis Applied To Life Science

Master'S Degree, Molecular Biology And Biochemistry, Magna Cum Laude

Bachelor'S Degree, Biology, Magna Cum Laude