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Magdalena MichulecMM

Magdalena Michulec

Quality and Compliance Advisor

€1,500/day
Zurich, CH
15+ years

Average response time: 1 hour

About Magdalena

Global Quality and Compliance leader with 20+ years of experience across industry, government agencies, and research institutions. Proven expertise in defining Quality Management System (QMS) strategies, leading Integrated Management System (IMS) transformations, and developing audit programs aligned with international and local regulations and standards. Lead auditor for ISO 9001 and ISO 13485. Skilled in leveraging technical expertise and interpersonal abilities to drive engagement, motivate teams, and enhance cross-functional collaboration for operational excellence.
  • English

    Native or bilingual

  • Polish

    Fluent

  • French

    Basic

  • German

    Basic

Can work on-site
Zurich (up to 50km)

Experience

  • Schneider Electric
    Global VP QMS
    November 2022 - Today (3 years and 7 months)
    Zürich, Switzerland
    • Orchestrated IMS governance for 350+ entities, driving management systems transformation.
    • Ensured compliance with ISO 9001, ISO 14001, ISO 45001, and ISO 50001 standards, collaborating with Notified Bodies to secure ISO certifications.
    • Oversaw a network of 2000 auditors maintaining quality standards across 50 countries.
    • Enhanced organizational capability by deploying advanced auditors training programs.
  • JABIL HEALTHCARE
    Senior Regulatory Compliance Manager
    March 2021 - October 2022 (1 year and 7 months)
    Balstal, SO, Switzerland
    • Led ISO 13485 compliance efforts across 9 EU sites, focusing on Medical Devices standards.
    • Supervised internal, supplier, and external audit programs.
    • Championed the development, implementation, and oversight of Continuous Inspection Readiness Programs, ensuring seamless compliance with regulatory standards.
  • Johnson & Johnson/ Jabil Healthcare
    Regulatory Compliance Manager
    April 2019 - February 2021 (1 year and 10 months)
    Solothurn, Switzerland
    • 6 months under Johnson & Johnson.
    • MD Orthopedics branch transferred to Jabil in October 2019.
    • Enhanced compliance with ISO 13485, EU MDR, FDA 21 CFR 820, and MDSAP regulations for robust quality management standards.

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Education

  • Doctor of Chemical Sciences (PhD)
    Gdansk University of Technology
    2005
    Doctor of Chemical Sciences (PhD)
  • Master of Science in Biotechnology
    Gdansk University of Technology
    2001
    Master of Science, Engineer (M.Sc. Eng.)

Certifications

  • Lead Auditor ISO 9001
    IRCA | International Register of Certificated Auditors
    2015
    QUALITY SYSTEMS AUDITING
  • Lead Auditor ISO 13485
    The Knowledge Academy
    2019

Skill set

Categories

  • Other