Beschreibung

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.

Branchenexpertise

Sprachen

Englisch
Muttersprachlich oder zweisprachig
Polnisch
Verhandlungssicher
Französisch
Grundkenntnisse
Deutsch
Grundkenntnisse

Arbeitsortpräferenzen

Vor Ort möglich

Zurich (bis zu 50 km)

Schneider Electric
Global VP QMS
November 2022 - Heute (3 Jahre und 7 Monate)
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
März 2021 - Oktober 2022 (1 Jahr und 7 Monate)
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 - Februar 2021 (1 Jahr und 10 Monate)
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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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.)

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

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Magdalena Michulec

Quality and Compliance Advisor

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