Fähigkeiten
Zusätzliche Fähigkeiten (3)
Branchenkenntnisse
Jurij in wenigen Worten
Highly committed Quality & Compliance expert with extensive track record in a regulated environment. Passionate about Quality Management with organizational and people leadership experience covering Quality Operations & Manufacturing, Strategic Quality & Regulatory Planning, Continuous Improvement, Supplier Quality, Customer Quality, Audit Management and EU-MDR/FDA/GMP/ISO/MDSAP regulatory expertise.Highly committed Quality & Compliance expert with extensive track record in a regulated environment. Passionate about Quality Management with organizational and people leadership experience covering Quality Operations & Manufacturing, Strategic Quality & Regulatory Planning, Continuous Improvement, Supplier Quality, Customer Quality, Audit Management and EU-MDR/FDA/GMP/ISO/MDSAP regulatory expertise.
Projekt- und Berufserfahrung
- Hamilton Medical / EU MDRProject Manager and Quality ConsultantMEDIZINJanuar 2019 - Oktober 2024 (5 Jahre und 9 Monate)Domat/Ems, Schweiz• Project Manager responsible for leading and coordinating of activities related to Medical Device Regulation (EU MDR) across different locations (CH/USA/GER/ROU/...), incl.:• project controlling and coordination of the ventilation devices and consumables• conducting project management activities such as GAP Analysis, planning and updating timelines, report status, defining work packages and setting up priorities• leading, collaboration and work hands-on with different stakeholders e.g., regulatory, quality, engineering, manufacturing, suppliers, business partners and notified bodies• review, planning and updating tasks for technical documentation, classification, PMS (including clinical Evaluation, PSUR, etc.), risk management, economical operators, EUDAMED, unique device identification (UDI), outsourced processes• updating and implementing new processes as required due to changed regulatory environment (e.g. introducing MIR form, reporting in UK in MORE database etc., registering economical operators and devices in EUDAMED and swissmedic)=> Achievement: EU-MDR certification for product portfolio of Hamilton Medical AG and medin Medical Innovations GmbH• Lead strategy and certification process for EN ISO 13485 at new established manufacturing facility in US. => Achievement: EN ISO 13485 certificate for Hamilton Medical Inc.• Project Leader for Compliance related to Brexit and UK MDR. Project in progress• QA/RA project member in three (3) development projects• Compliance Expert for Technology Transfers and Global Quality Alignment topics
- YPSOMEDConsultant – Interim Quality ManagerJuli 2018 - Dezember 2018 (5 Monate)Hermann-Burgdorf-Straße, Buchholz in der Nordheide, NI, Germany• Planning and handling the overall activities for assuring quality and compliance within Diabetes Care Business Unit (Insulin Pump System: Hardware, Software (embedded+app), Touchscreen, delivery system; Infusion sets; Needles)• Review and Release of Qualification and Validation documents concerning cleanroom, test methods, risk files; QA Lean-Project member to increase production line capacity• Products/ Batch release of finished goods and subassemblies• Product Care and PMS Team member for Diabetes Pump. Support for new established site in Germany. Subject Matter Expert for qualification and validation activities• MDSAP Audit support and SME for CAPA and Change Management
- Zimmer Biomet/ Consultant - Supplier Quality EngineerFebruar 2018 - Juni 2018 (4 Monate)Switzerland• Implementation of UDI (Unique Device Identification) internally and at supplier site (15x)• Traceability project, Direct Part Marking Study + Implementation• Analysis and implementation of test methods, validations, measurements (MSA; Gage R&R), risk analysis acc. to ISO14971, FMEA, Quality Control Plans• Qualification/Validation and approval ofoutsourced manufacturing processes incl. audits• Evaluation and process monitoring (capability, robustness), documentation/evaluation of product contact materials (REACH, California proposition and RoHS compliance)
Externe Empfehlungen
Ausbildung und Abschlüsse
- Clinical-Medical TechnologyRheinische Friedrich-Wilhelm Universität Bonn (M.Sc)2017Clinical-Medical Technology
- Bio-Medical Engineering (Bio-Medizintechnik)Hochschule Furtwangen University2014Bio-Medical Engineering (Bio-Medizintechnik)
Zertifizierungen
- Internal Auditing to the Medical Device Single Audit Programm Including ISO 13485:2016 and Device Regulations from MDSAP JurisdictionsOriel STAT A MATRIX2023
- Product Certification: CE and UKCA MarkingBSI Training Academy2022
- ISO 13485:2016 Lead Auditor Training CourseBSI Training Academy2021
- Clinical evaluation of medical devicesTÜV SÜD2020
- Medical Device Regulation (EU) 2017/745SAQ Qualicon2021
- Manager Regulatory Affairs International - TÜV - Medical DevicesTÜV SÜD2018
- Specialist Technical Documentation - TÜV - Medical DevicesTÜV SÜD2018
- Specialist Managementsystems - TÜV - Medical DevicesTÜV SÜD2018