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Summary

highly motivated professional in the area of Quality Management, Project Management, Regulatory Affairs and ehs with a sense of Leadership. working experience in different industries, such as telecommunication, construction, automotive, Medical Device. comfortable in interacting with all levels of the organization and public. able to negotiate and quickly, accurately and efficiently Problem Solving. adept at multitasking to achieve company, team and individual goals. quality, excellence and just in time approach.

Experiences

Current Experience

  • Head of Quality - QA/RA


    Since October 2015
    - Quality Assurance and regulatory requirements for Medical Devices (digital radiography systems, sterilizer, image acquisition systems and medical Software) - managing of qms Compliance to the requirements of ISO 13485, ISO 9001, mdd 93/42/eec, FDA cfr 820; - coordinating preparation and maintenance of technical files for Medical Devices according directive mdd - 93/42/eec directive - leading regulatory/supplier/qms audits, support in conducting Root Cause Analysis (rca) and corrective and preventive actions (capa) - implementation of requirements for production license from serbian ministry of Health (GMP norms) - monitoring and analysis of customer complaints and defects - risk analysis for Medical Devices and risk file maintenance (according iso14971) - provide regulatory Documentation for submissions to other regulatory agencies and Product registration at foreign market - maintaining registration of Medical Devices at agency of drugs and Medical Devices of serbia (alims) - providing Training of employees for quality and hse awareness - Quality assurance and regulatory requirements for medical devices (digital radiography systems, sterilizer, image acquisition systems and medical software) - Managing of QMS compliance to the requirements of ISO 13485, ISO 9001, MDD 93/42/EEC, FDA CFR 820; - Coordinating preparation and maintenance of technical files for medical devices according directive MDD - 93/42/EEC directive - Leading regulatory/supplier/QMS audits, support in conducting Root cause analysis (RCA) and corrective and preventive actions (CAPA) - Implementation of requirements for Production License from Serbian Ministry of Health (GMP norms) - Monitoring and analysis of customer complaints and defects - Risk Analysis for Medical Devices and Risk File maintenance (according ISO14971) - Provide regulatory documentation for submissions to other regulatory agencies and product registration at foreign market - Maintaining registration of medical devices at Agency of Drugs and Medical Devices of Serbia (ALIMS) - Providing training of employees for quality and HSE awareness

Past Experience

  • QMS Engineer

    February 2015 --- October 2015
    - establishing, implementing and maintaining qms in accordance with law and standards (ISO 9001, 14001 and iso ts 16949) - developing integrated management system Documentation - assuring Documentation conformity with requirements of standards (ISO 9001, 14001 and iso ts 16949) - Planning, organizing and conducting internal audits - analyzing results of internal and external audits - providing support in implementing corrective actions - organizing and conducting Training for quality tools and process improvement, as for management systems, within company - continuous improvements of processes and Quality System in cooperation with process owners - reporting to quality manager about audit reports and quality issues

  • Head of Quality Department/Management Representative

    October 2008 --- February 2015
    - process mapping and ensuring that the processes needed for integrated management system (ISO 9001, iso 14000 and ohsas 18000) are implemented and maintained - preparing, reviewing and update all documents related to integrated management system (ims) - conducting Internal Audit, defining corrective and preventive actions - reporting to the top management about ims efficiency (objectives, kpi's) - making contacts with certification bodies; institutions for quality and standards; customers,end users and stakeholders - providing Training to improve personnel competence - ensuring that the occupational safety and Health activities and actions are implemented and conducted - tracking project realization - collecting offers and negotiating with subcontractors - creating project schedule (gantt chart) - communications and problem handling with consumers, vendors and subcontractors - preparing all Documentation needed for the project takeover (attests, certificates, test reports etc)

  • Quality Engineer and Site Acquisition Coordinator

    October 2007 --- October 2008
    - developing Quality Management System Documentation - conducting Internal Audit and defining corrective and preventive actions - coordinating the work of the site acquisition officers (site for mobile operator equipment) - negotiating with site owners for rent agreement - contacts with subcontractors for construction works on the site - tracking work progress on the site - coordinating equipment delivery and installation on the site - sending progress reports to the investor (done/plan report)

Knowledge

LinkedIn Assessment :
Quality ManagementQuality SystemProject PlanningProject ManagementISOSix SigmaISO 9000Process improvementmanagementISO 14001Continuous ImprovementQuality AssuranceQuality AuditingEnvironmental Management SystemsTeam LeadershipRisk ManagementTeam ManagementNegotiationTestingTime ManagementTrainingInternal AuditAnalysisEngineeringKaizenManufacturingOccupational HealthLeadershipProcurementSoftware DocumentationLean ManufacturingRoot Cause AnalysisAuditingProcess MappingProcess ManagementScope ManagementSupplier NegotiationBusiness Process MappingBusiness Process ImprovementMS ProjectProcess EngineeringHuman ResourcesContract ManagementChange ManagementBusiness ProcessRisk AssessmentERPCE markingISO 13485ISO 14971

Education

  • MBA in Business Administration (MBA) from PwC Academy in 2017
  • M.Sc in quality management from Faculty of Organisational Sciences in 2006

Training and Certification

  • QMS Lead Auditor in 0000 Certification

Languages

BrightOwl Assessment:
Self Assessment:
Serbian
Native
English
Full Proficiency
Italian
Elementary Proficiency
German
Elementary Proficiency

Area / Region

Serbia, Belgrade

Others

Driving License
  • Yes

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