Louis Leenheers

Medical Device & IVD QMS Expert - Simplification - From Overcomplexity to Smart Compliance

Limoges, Nouvelle-Aquitaine, France

About

Ambitious and experienced quality and customer service manager, with a broad business background. Enthusiastic team motivator with a strong drive and target orientation. Logic and objective, with an excellent sense for compliance, customer needs and commercial opportunities.

Experience

  • QMS Director at Organon
    Aug 2021 - Present · 4 yrs 11 mos

  • bioMérieux (19 yrs 5 mos)
    • Senior Director, Global Quality
      Jan 2012 - Nov 2020 · 8 yrs 11 mos

      Mission: Implement, maintain, and continuously improve the quality management systems of the bioMérieux manufacturing sites and subsidiaries. Simplify and harmonize the global quality processes for complaint management, vigilance, training, documentation, and communication, to meet and anticipate customer expectations in an evolving regulatory environment. How: Manage teams of Quality Experts. Have regular meetings with the corporate network of QMS representatives. Conduct internal audits and perform gap assessments to survey compliance with domestic and international guidelines, corporate standards, and local procedures. Develop realistic plans to address the non-conformities and points for improvements. Main achievements: • Simplified the complaint handling process and reduced the time to answer by 25% • Defined a standard watch process that provides identification, evaluation, and if necessary, implementation of standards through the bioMérieux Quality Management System • Implemented a new e-QMS for the management of MDR and adverse events • Harmonized the quality training offer and increased the number of trainees by a factor 5 • Simplified the quality documentation structure by reducing the number of documents with 20% • Executed corporate quality audits world-wide

    • Executive Director, Global System Support
      Jul 2009 - Dec 2011 · 2 yrs 6 mos

      Mission: To provide the finest customer service in everything we do, and to sell quality products at a great value, while exceeding our customers’ expectations. Provide 2nd level support to all bioMérieux application specialists and service engineers of 44 bioMérieux subsidiaries and of more than 100 international distributors. How: Leading a team of 42 application specialists and service engineers in France and the US. Manage, lead, and accomplish goals through others by utilising plans, strategies, and referring them to existing practices for guidance. Main achievements: • Successfully integrated the Organon Teknika customer service structure into the bioMérieux organization • Creation of a sustainable quality culture in customer service • Implementation of a new electronic complaint handling management system

    • Director, Global Customer Service
      Jul 2001 - Jun 2009 · 8 yrs

      Mission: Provide technical assistance and training to all bioMérieux application specialists and service engineers world-wide. How: Leading a team of 15 application specialists and service engineers, to provide technical training and support to all bioMérieux subsidiaries and international distributors. Main achievement • Managed to let local entities solve more than 90% of all inquiries themselves. Less than 1% escalated to 3rd level • Promoted as director in 2002 when bioMérieux acquired Organon Teknika • Proposed by top management of bioMérieux to move to France when the Dutch facilities were closed in 2009

  • Commercial Engineer and Trainer, International Manufacturing and Support at Organon Teknika
    Jan 1990 - Jun 2001 · 11 yrs 6 mos

    Mission: Guarantee a successful commercialisation of new In-Vitro Diagnostic products and to shorten the time to market. How: Being involved in R&D projects in an early phase, taking care that all aspects needed for a successful launch were covered by the project team. Defining the final (and internal) customer expectations, using checklists, and discussing with the team on a regularly basis, to ensure completion within the timelines agreed upon. Main achievements: • Accompanied successfully new IVD products from R&D to commercialisation as scheduled • Developed new and innovative test methods to guarantee the quality of RNA amplification tests

  • Quality Control Engineer at Organon
    Sep 1986 - Dec 1989 · 3 yrs 4 mos

    Mission: Guarantee the quality during all the process from raw material to finished product of In-Vitro Diagnostic products that are developed, manufactured, and marketed by the company. How: Testing and releasing various types of IVD products (ELISA, Pregnancy tests, etc.) and finding solutions and/or proposing rework for products that did not meet all the requirements. Main achievement: • Contributed to the commercial success of the Predictor pregnancy tests (world-leader) • Reduced the amount of rejected products