Bella Mitsel, ME

QA & RA Medical Device Project Manager

Bella Mitsel holds B.Sc. in Biotechnology and, M.E. in Quality and Reliability from Technion Institute and a Lead Auditor Certificate from SII. 

Before Joining Gsap Bella worked in Equashield Medical Ltd and Medimop (West Israel) as Quality Manager and Quality Engineer. During her previous positions, Bella has established and lead Quality Management Systems in accordance with ISO 13485 and 21 CFR part 820 requirements.     

Managing quality processes such as Customer Complaint handling, CAPA, Change Control, Nonconforming handling, training and qualification, performing internal; vendor and external audits, approving equipment, computer systems and processes validations, preparing and performing sterilization validations, sterile barrier systems validations (packaging machines, transportation & shelf life validations) and clean room validation. 

In the Regulatory field, she acquired knowledge and practice in monitoring R&D projects, Design Controls, creation & implementation of Risk Management in production and development, establishing QMS and a technical documentation for virtual manufacture (OBL-OEM), regulatory submissions, performing Clinical Evaluation, setting up regulatory requirements and building FDA Master File, Design History files and Maintenance of the technical file.

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