Wioletta Kowacz
Project Manager at Medinice S.A.- Claim this Profile
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Bio
Credentials
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PMBOK Essentials
Project Management InstituteMar, 2023- Sep, 2024 -
Learning Design Thinking: Lead Change in Your Organization
LinkedInJul, 2021- Sep, 2024 -
Microsoft Project 2016 Essential Training
LinkedInMay, 2021- Sep, 2024 -
Design Thinking: Understanding the Process
LinkedInApr, 2021- Sep, 2024 -
Information Security Management Systems Auditor/ Lead Auditor Training Course (BS ISO/IEC 27001:2013)
BSIDec, 2014- Sep, 2024 -
Business Continuity Management Systems Auditor/ Lead Auditor Training Course (ISO 22301)
BSIAug, 2013- Sep, 2024 -
IEMA Approved Lead Environmental Auditor Course (UK) (ISO 14001:2004)
BSIJun, 2012- Sep, 2024 -
Quality Management Systems Auditor/ Lead Auditor Training Course (ISO 9001:2008)
BSIApr, 2011- Sep, 2024 -
Poświadczenie bezpieczeństwa w zakresie dostępu do informacji niejawnych oznaczonych klauzulą POUFNE
Polska Wytwórnia Papierów Wartościowych S.A.Jul, 2013- Sep, 2024 -
Certyfikat Auditora Wewnętrznego
SGS Polska S.A. -
Certyfikat Auditora Wewnętrznego normy ISO 13485
SGS
Experience
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Medinice S.A.
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Poland
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Medical Equipment Manufacturing
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1 - 100 Employee
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Project Manager
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Jun 2023 - Present
• Planning tasks, project activities, schedules, budgets, allocating resources to tasks and controlling their implementation • Monitoring progress, work results and key aspects of the project in a measurable way and reporting • Creating comprehensive management documentation and supervising project documentation • Conducting negotiations with subcontractors • Coordination of project team members (incl. work with subcontractors) • Planning tasks, project activities, schedules, budgets, allocating resources to tasks and controlling their implementation • Monitoring progress, work results and key aspects of the project in a measurable way and reporting • Creating comprehensive management documentation and supervising project documentation • Conducting negotiations with subcontractors • Coordination of project team members (incl. work with subcontractors)
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HTL-STREFA S.A.
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Poland
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Medical Equipment Manufacturing
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100 - 200 Employee
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Design Quality Assurance
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Jun 2018 - Jun 2023
• leading of a smaller R&D projects (eg. implementation of a new version of the medical device)• leading of projects related to an external suppliers implementation• planning of the R&D projects• coordination of the project tasks in a line with a time schedule and Change Control• direct support of a Project Managers and PMO• preparation of summaries and presentation for management• DHF/TF preparation• ensuring of the QA compliance in design process in accordance with the implemented QMS based on external standards and regulations (ISO, MDD/MDR, FDA)• determination and implementation of activities related to the usability of medical devices (based on IEC 62366, FDA guide) [like previous position] Show less
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Specialist for Product Usability
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Feb 2017 - May 2018
• application of usability engineering to medical devices (IEC 62366), preparing a usability documentation (incl. formative and summative evaluation, HFE reports in accordance with FDA requirements or MDR)• conducting individual interviews (IDI) with representatives during usability studies for medical devices (new projects, changes in existing products)• building and evaluation of the labelling content and graphic presentation• benchmarking and medical devices market research• risk evaluation for medical devices on the basis of ISO 14791 Show less
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Senior Specialist for Management Systems
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Mar 2009 - Jan 2017
- Risk Management - defining standards and methods of risk analyzes, conducting risk analysis for processes carried out in several departments, building risk treatment plans, monitoring plans (including in the field of information security, valuable production safety)- Project management (compliance manager) - leading a 25-person interdisciplinary team task, develop a timetable and documentation, monitoring tasks, determining the required organizational and technical changes of the newly implemented standards,- Integrated Management System - implementation of new standards throughout the company, leading a team of auditors during the audits in foreign suppliers, internal audit (security printing valuable processes, information security, business continuity, quality, environment, health and safety), the creation of internal regulations (procedures , instructions, rules, regulations, etc.), training,- Process management - process mapping, process optimization, metering and monitoring processes (Statistical Methods of Analysis of Processes - SPC, KPIs, 5Why, 8D), conducting strategic session on building strategies and objectives. Show less
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Specialist for Strategy Planning
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Nov 2007 - Feb 2009
- Process Management - SWOT analysis, building a strategic plan for the company, market and competition analysis, analysis of benchmark enterprises (financial, technological, quality, organization, etc.), preparation of commercial and financial reports,- Management by objectives - development goals according to the SMART method, cascading targets under the scheme: corporate purposes - business objectives - operational objectives.
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Specialist for Information Security
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Sep 2003 - Oct 2007
- Risk management - an analysis of the risk of information security, preparation of plans for dealing with risk and information security policies,- Protection of personal data - conducting internal training on the protection of personal data, acting as a Security Administrator Groups Information, cooperation in building a system of safety management of personal data processed in ICT systems company and customers, control of information and communication systems for the protection of personal data, service and solving incidents related to information security and the functioning of national systems. Show less
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Education
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2005 - 2007
Warsaw School of Economy
Master of economics, Economy -
2015 - 2016
Uniwersytet Warszawski (Warsaw University)
Internal Security - postgraduate studies -
2002 - 2005
Akademia Polonijna w Częstochowie
Licentiate degree, Economical Law
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