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Maria PetroniMP

Maria Petroni

MedTech QA/RA Specialist - Device Engineer

250 €/jour
Zurich, CH
3-7 ans
Technical Documentation
QMS Compliance (EU/CH/USA)
Post-Market Surveillance (Process Owner)
Regulatory Documentation & Submission
Product Lifecycle Management

Délai de réponse moyen : 1h

À propos de Maria

Chartered Engineer (Ing.). MSc in Nuclear Engineering with a specialisation in Biomedical Engineering & Medical Technology.

Technical background covering diagnostic, therapeutic, surgical, implantable, and radiation‑based technologies, including combination products and IVDs. Strong foundation in Mechanical Engineering.

Hands‑on experience across QA, RA, and Device Engineering for Class I–III medical devices, with exposure to the full lifecycle: Design & Development, Design Control, Risk Management (ISO 14971), HW/SW V&V, Technical Documentation, regulatory compliance, and PMS for EU/CH/US markets.

Experience as PMS Process Owner, developing global PMS processes and delivering data‑driven inputs (KPIs, trends, reports) to support regulatory and product decisions. Contribution to lifecycle activities while managing daily QA/RA operations.

Certified ISO 13485 Lead & Internal Auditor (BSI), supporting internal and external audits through evidence‑based compliance.

Professional references confirm accuracy, reliability, autonomy, adaptability, consistent performance under pressure, and effective cross‑functional collaboration.

𝐂𝐨𝐫𝐞 𝐂𝐨𝐦𝐩𝐞𝐭𝐞𝐧𝐜𝐢𝐞𝐬:
● ISO 13485 QMS · MDD · EU MDR (Transition and Remediation) · Swissmedic · FDA 21 CFR 820 · CE Marking
● Regulatory Submission (EU/CH/US)
● Technical Documentation (DHF, DMR, Technical Files, GSPR)
● ISO 14971 Risk Management · Risk‑Benefit Analysis · Design Control
● CAPA Management · Deviations/NCs · Change Control · Labelling
● Post-Market Surveillance/ Process Owner (SOPs, Plans, Reports, PSUR, Trend Analysis, KPIs)
● Audit & Inspection Readiness · Notified Body and Swissmedic interactions
● IEC 62304 HW/SW V&V · Usability Engineering (IEC 62366) · GMP Documentation
● Cross‑functional Collaboration (R&D, Manufacturing, Consultants, Suppliers)

Italian (native), English (fluent), German (B2, progressing to C1), French (A2)
Équipement médical

  • Anglais

    Capacité professionnelle complète

  • Allemand

    Capacité professionnelle limitée

  • Français

    Notions

  • Italien

    Bilingue ou natif

Accepte de travailler sur site
Zurich (jusqu’à 10 km), Basel (jusqu’à 10 km), Zug (jusqu’à 10 km), Aarau (jusqu’à 10 km), Solothurn (jusqu’à 10 km)

Expériences

  • myself
    Professional Development – Regulatory Affairs
    août 2024 - Aujourd'hui (1 an et 10 mois)
    Würenlos, AG, Switzerland
    Advanced QA/RA training (Medical Devices/Pharma) · Participation in Swiss MedTech networks and regulatory events · German training B2→C1 (ongoing)
  • Z-Systems AG
    QA/RA Specialist – Deputy QA/RA – Deputy CH-PRRC
    SECTEUR MÉDICAL
    septembre 2021 - juillet 2024 (2 ans et 10 mois)
    Oensingen, SO, Switzerland
    Zirconia dental implants (Class I-III)
    • Supported daily QA/RA operations as Deputy QA/RA and Deputy CH‑PRRC, with functional responsibilities
    • Developed PMS SOPs, templates, plans, and reports using MDR/MedDO and ISO 13485 requirements to ensure compliant PMS documentation (Process Owner)
    • Updated QMS and Technical Documentation via controlled workflows to improve traceability and audit readiness
    • Performed RCA and follow‑up activities using structured NC/CAPA methods to stabilise issue handling
    • Coordinated external consultants for Risk Management deliverables to maintain accurate and compliant files
    • Prepared QMS/PMS evidence for audits to ensure inspection‑ready documentation
    • Provided PMS trend data, risk‑management inputs, and structured evidence to support regulatory decision‑making and Management Review
  • Acutronic Medical AG (Vyaire Medical, U.S)
    Senior Product Quality Engineer
    juillet 2019 - juin 2021 (1 an et 11 mois)
    Hirzel, ZH, Switzerland
    Life-support ventilators (Class I/IIb/III)
    • Executed HW/SW V&V using risk‑based protocols and ISO 14971 tools to verify ventilator performance
    • Maintained DHF/DMR through controlled updates to support design transfer and compliance
    • Performed FMEAs and traceability matrices to strengthen design assurance
    • Investigated HW/SW failures using troubleshooting and RCA to support complaints and field investigations
    • Prepared documentation for submissions and audits using controlled QMS records to ensure inspection‑ready files
    • Contributed to design assurance and risk‑management activities with functional responsibility for documentation
Consulter toutes les expériences de Maria

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Formations

  • Chartered Professional Engineering Certificate (Ing.) in Nuclear engineering with Major in Biomedical Engineering (Medical Devices/Combination Products/IVDs)
    University "La Sapienza"
    2011
    Licensed Professional Engineer (Ing.), certified through national written and oral examinations and registered with La Sapienza University and the Rome Engineers’ Council as a fully accredited professional engineer.
  • MSC in Nuclear Engineering with major in Biomedical Engineering (Medical Devices/Combination Products/IVDs)
    University "La Sapienza"
    2010
Consultez la formation qu'a suivie Maria

Catégories

  • Autre