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Mélanie SALVADO

THONON LES BAINS

En résumé

Multilingual executive with 13 years quality, regulatory and legal experience; 10 years of which in a Quality function . Commitment, a strong eye for detail and technical skills as well as analytical, communication and organisation skills are some of the qualities that make me a successful individual.

Mes compétences :
English
FLUENT
Fluent English
French
German
ISO 13485
Iso 14001
ISO 14971
ISO 19011
ISO 9001
Microsoft Pack Office
SAP
Sap R3
Trackwise

Entreprises

  • Debiotech - Quality Director

    2014 - maintenant

  • EMS Electro Medical Systems - Quality Engineer

    2013 - 2014

  • Becton Dickinson - WW Project Quality Engineer

    Le Pont de Claix 2011 - 2012 WW Project Quality Engineer – Packaging (Syringes) for Pharmaceuticals / Medical Device
    BECTON DICKINSON Grenoble – WW Quality Engineering Department
    I’m involved in :
    All of the Quality Management activities during each step of the Quality Management Plan:
    • Concept Phase
    • Definition phase
    • Development phase
    • Qualification phase
    • Launch phase
    Main Tasks :
    Ensuring that all aspects of the product development cycle have been addressed, documented,
    verified and validated
    Establish quality statements regarding customers needs and regulation (Phthalates, Latex,
    Biocompatibility, Pharmacopoeia, BSE/TSE…)
    Ensuring product safety and efficacy
    Developing a close relationship with other quality functions
    Assessing project activities for quality assurance and compliance
    Conducting Failure investigations and problem solving sessions
    Evaluating Customer Requirements to identify which quality standards are applicable
    Initiating projects and generating Quality answer
    Developing Quality plans (development and manufacturing)
    Lead risk management activities
    Ensuring that the design control elements are satisfied
    Ensure that the process validation activities are completed
    Define and conduct a supplier qualification plan
    Evaluate test methods used in project activities
    Release product during project phases (clinical trials, customer samples, validation batches…)

  • NEWDEAL SAS - Quality System Coordinator

    2007 - 2010 2007 – 2010 Quality System Coordinator – Medical Device
    NEWDEAL Lyon – INTEGRA Lifesciences Group – Quality Department
    I’m involved in :
    - Quality management in an international environment
    - Coordinate the process approach (reviews, monitoring of the processes…)
    - Organizing biannual management reviews (with management rep. and corporate)
    - Plan the quality, and conduct audits as lead auditor (internal, external - suppliers, technical files)
    - Perform quality trainings (QSR, cGMP 21 CFR 820, 803, 806 et 11, NF EN ISO 13485, NF EN ISO 9001, RIM, new starter)
    - Follow third part audits performed by SGS for ISO 13485, CE Mark 93/42/EEC, ISO 9001 and ISO 13485 CMDCAS.
    - Monitore CAPAs and Document Change requests
    - Standard monitoring (via SNITEM, EUROPA, AFNOR, ASTM, TC 210…)
    - Product materials approvals and Facility label approvals

    Results :
    - Harmonization of the QMS in compliance with corporate requirements
    - Implementation of requirements of 93/42/EEC amended by 2007/47/EEC Directive
    - FDA environment kept in mind from all the employees

  • TREFILEUROPE - Quality System Coordinator

    2004 - 2006 2004 - 2006 Quality System Coordinator – Steel Industry
    TREFILEUROPE Bourg en Bresse – MITTAL STEEL Group – Quality Department
    Main mission:
    - Obtain the ISO 9001 certification
    - Rebuilt the QMS
    - Set up a new process approach based on a « one page strategy »
    - CAPA monitoring,
    - Conduct workshops for quality improvements
    - Conduct Internal Audits as lead auditor according to ISO 19011
    - Set up the processus approach, define pilots, and processus reviews

    Results :
    - ISO 9001 v.2000 certification obtained in May 2006,
    - New QMS (before : 570 procedures and work instructions – after : 25)

  • SANOFI PASTEUR - Legal Administrative Assistant

    Lyon 2001 - 2004 2001 - 2004 Legal Administrative Assistant – Pharmaceuticals
    SANOFI PASTEUR Lyon –SANOFI AVENTIS Group – Legal Department

Formations

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