Marcelina Gans

Angestellt, Senior Project Engineer/auditor - Sterilization || MDD/MDR || ISO13485 || MDSAP, UL International Polska Sp. z o.o.

Stettin, Polen

Fähigkeiten und Kenntnisse

Audit
Radiation
ISO 13485
Ethylene oxide
Sterilization
MDSAP
MDD
MDR
Gamma
X-Ray
E-beam
Professional experience
FDA Regulation
Biocompatibility
Cleaning and disinfection
Medical Microbiology
Quality Management
Quality standards
ISO 11135
ISO 11137
ISO 11737-1
ISO 11737-2
ISO 10993
ISO 11607
Process Validation
Verification and validation
design control
Risk Management
ISO 14971

Werdegang

Berufserfahrung von Marcelina Gans

  • Bis heute 3 Jahre und 3 Monate, seit März 2021

    Senior Project Engineer/auditor - Sterilization || MDD/MDR || ISO13485 || MDSAP

    UL International Polska Sp. z o.o.

    Sterilization Specialist (E0, Radiation, Moist heat, Dry heat) and currently under training to be a full time ISO 13485/MDD/MDR/MDSAP auditor and product reviewer. I have extensive experience working in laboratories of pharmaceutical and medical companies. My main areas of expertise are sterilization of medical devices, biocompatibility, cleaning and disinfection, design control, risk management and microbiology (related with manufacturing of medical devices and sterility assurance).

21 Mio. XING Mitglieder, von A bis Z