Juraj Voloch
Director, Medical Device Engineering Validation and Testing
- Role
- Director, Medical Device Engineering Validation and Testing at AbbVie
- Location
- San Francisco, CA, US
- LinkedIn followers
- 500 followers
About Juraj Voloch
Results focused senior manager with international work experience in Medical Devices and Combination Products Engineering, Quality, Regulatory and Program Management • 20 years of complex background in Medical Device Engineering, Quality and Post Market Surveillance • Class Medical Devices and Combination Products development including Software • Proven experience in leading a global teams of project, engineering and quality managers • SME in QMS gaps identification, QMS building and Risk Management • Broad device background including Product Definition, Design Control, PMS, UX and Human Factors, V&V • Proficient in 21 CFR 820, 21 CFR 4, ISO 13485, ISO 14971, IEC 62304, IEC 62366, MDD, MDR, cGMP, CLIA, HIPAA • Multilingual: English, German, Russian, Ukrainian, Czech Polish, Slovak Domain background: Medical Devices, Combination Products, Clinical Workflow, Record & Verify, PACS, OIS, HIS, TPS, EHR, EMR, ICD, Patient Positioning, Treatment Delivery, Imaging, Interoperability, DICOM, Treatment Planning, Treatment Delivery, Surgical Planning, CyberSecurity, Audits, Blockchain, DApp Product Domains: Radiation Oncology, Orthopaedics, Digital Pathology, Molecular Imaging, Pharmaceuticals - Biotech Focus: • Medical Device products Development, Quality, Risk Management, Verification & Validation • Identifying gaps, implementing and improving Medical Device design and processes Supported by experience in: • Medical Device Engineering and Quality Management / Design Control • Medical Device Regulatory (EMA, FDA) • Cross-functional Project and Program Management • Quality Management / Quality Management System • Product Management / Product Definition
Experience
Director, Medical Device Engineering Validation and Testing
Apr 2022 — Present · US
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