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Maria PetroniMP

Maria Petroni

MedTech QA/RA Professional & Devices Engineer

€250/day
Zurich, CH
3-7 years
Technical Documentation
Product Lifecycle Management
Regulatory Submissions (EU/CH/USA)
ISO 13485 QMS Compliance
Post-Market Surveillance

Average response time: 1 hour

About Maria

Chartered Engineer (MSc in Nuclear Engineering, Major in Biomedical Engineering & Medical Technology) with 5+ years of experience in QA/RA and Device Engineering for Class I–III medical devices in EU, CH and US markets.

BSI‑certified ISO 13485 Lead & Internal Auditor.

I help MedTech companies reduce compliance risks, close documentation gaps and maintain audit‑ready QMS/PMS processes. I support Design Control, risk management, V&V, Technical Documentation, regulatory submissions and audit preparation.

Key achievements include QMS/PMS strengthening, structured CAPA, documentation remediation, MDR audits with zero major findings, and HW/SW testing to improve product reliability.

𝐂𝐨𝐫𝐞 𝐂𝐨𝐦𝐩𝐞𝐭𝐞𝐧𝐜𝐢𝐞𝐬:
● ISO 13485 QMS · EU MDR (transition & remediation) · MedDO · FDA 21 CFR 820 · CE Marking
● Regulatory Submissions (EU/CH/US)
● Technical Documentation (DHF, DMR, Technical Files)
● ISO 14971 Risk Management · Design Control
● CAPA & NC Management · Change Control · Labelling
● Post‑Market Surveillance (SOPs, Plans, Reports, PSURs, Trend Reports, - Process Owner)
● Audit & Inspection Readiness · Notified Body & Authority interactions · QA process defence
● HW/SW V&V · IEC 62366 · IEC 62304 · GxP compliance · Supplier Quality Management
● Cross‑functional Collaboration (R&D, Manufacturing, Consultants, Suppliers, etc)
● Mechanical Engineering & radiation applications in controlled industrial/medical environments

𝐃𝐞𝐯𝐢𝐜𝐞 𝐄𝐱𝐩𝐞𝐫𝐢𝐞𝐧𝐜𝐞:
Lung Ventilators · Orthopaedic Implants · Zirconia Dental Implants · X‑ray CT Scan Systems

Available for short or long‑term projects, documentation remediation, audit preparation and ongoing QA/RA support.
Medical Devices

  • English

    Fluent

  • German

    Conversational

  • French

    Basic

  • Italian

    Native or bilingual

Can work on-site
Zurich (up to 10km), Basel (up to 10km), Zug (up to 10km), Aarau (up to 10km), Solothurn (up to 10km)

Experience

  • Freelance
    Freelance & Professional Development (QA/RA)
    August 2024 - Today (1 year and 11 months)
    Würenlos, AG, Switzerland
    QMS optimisation, PMS, Technical Documentation remediation.

    Advanced QA/RA training (Medical Devices/Pharma) · Participation in Swiss MedTech networks and regulatory events · German training B2→C1 (ongoing)
    Quality Assurance Regulatory Affairs German language Medical Devices Pharma
  • Z-Systems AG
    QA/RA Specialist – Deputy QA/RA – Deputy CH-PRRC
    MEDICAL
    September 2021 - July 2024 (2 years and 10 months)
    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
    ISO 13485 QMS Post-Market Surveillance (Process Owner) Audit Regulatory Submission EU MDR Transition & Remediation
  • Acutronic Medical AG (Vyaire Medical, U.S)
    Senior Product Quality Engineer
    July 2019 - June 2021 (1 year and 11 months)
    Hirzel, ZH, Switzerland
    Life-support ventilators (Class I-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
    Technical Documentation Verification and Validation Risk Management Design Control Product Investigation
Check out Maria's experience

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Education

  • 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
Check out Maria's education

Categories

  • Other