Thierry Monnier

About

Recognized Quality and Operation management in Medical Device industry. Skilled in multidisciplinary team management. Proven achievements in all functions of Quality : - Quality System with successful audits (2 FDA, 2 MDSAP, 15 ISO13485 audits without 483 nor major findings) ; - Quality Engineering with 15 years envolvement in equipment and process validations ; - Quality Operation with over 20 years experience on in-coming, in-process, final inspection including product release. Strong skills in statistics (6-sigma, lean), problem solving (DMAIC), validation (IQ, OQ, PQ, GR&R) and team management. French native language, fluent in English and good German knowledge.

Experience

• Quality Manager at Codec SA
  Mar 2018 - Present · 8 yrs 4 mos

• Medtronic (16 yrs 8 mos)
  • Sr Quality Manager
    Dec 2012 - Present · 13 yrs 7 mos

    QS mangement (1 FDA; 2 MDSAP, 5 ISO 13485 audits) QE management (Product/process validations) QO management (incoming/in-process/final inspection)

  • Quality Manager
    Nov 2009 - Dec 2012 · 3 yrs 2 mos

    QS mangement (1 FDA; 3 ISO 13485 audits) QE management (Product/process validations) QO management (incoming/in-process/final inspection)

• Johnson & Johnson (7 yrs 7 mos)
  • QE&QC Manager
    Jul 2007 - Oct 2009 · 2 yrs 4 mos

    Team management Process/product validation Quality operation management

  • QE&QC Manager
    Apr 2002 - Jun 2007 · 5 yrs 3 mos

    Team management Process/product validation Quality operation management

• QA Manager at Ismeca
  Sep 1995 - Apr 2002 · 6 yrs 8 mos

  Certification ISO 9001 Team management Quality System management Validation Metrology

• Sales Engineer at Union Tool Europe SA
  May 1992 - Aug 1995 · 3 yrs 4 mos

  European Sales technical support