Experience

Nestmedic S.A.

• Poland
• Medical Equipment Manufacturing
• 1 - 100 Employee

• • Jan 2022 - Present

  Quality Management Representative.Maintaining Quality Management System according to ISO 13485:2016.Ensuring compliance with regulatory requirements such as MDR, MDD regulations.Ensuring compliance with requirements such as ISO 13485:2016 and 21CFR820.Establishing and improving processes. Ensuring compliance of processes such as CAPA, Risk Analysis, Software Validation, Management Review, Trainings, Change Management.Training staff on EN ISO 13485:2012, legal requirements related to medical devices and internal auditing.Creation, verification and negotiation of the Quality Agreements.Building of Internal Audits process and its Management as Audit Program.. Carrying out Internal and External Audits (e.g. Suppliers, Subcontractors).Contacting external supervisory authorities.Representing company during the Audits/Inspections of Supervisory Authorities such as Notified Body and Customer visits/audits.Qualification of manufacturers.Team Management. Show less

• • Jul 2019 - Dec 2021

  Quality Management Representative.Maintaining Quality Management System according to ISO 13485:2016.Ensuring compliance with regulatory requirements such as MDR, MDD regulations.Ensuring compliance with requirements such as ISO 13485:2016 and 21CFR820.Establishing and improving processes. Ensuring compliance of processes such as CAPA, Risk Analysis, Software Validation, Management Review, Trainings, Change Management.Training staff on EN ISO 13485:2012, legal requirements related to medical devices and internal auditing.Creation, verification and negotiation of the Quality Agreements.Building of Internal Audits process and its Management as Audit Program.. Carrying out Internal and External Audits (e.g. Suppliers, Subcontractors).Contacting external supervisory authorities.Representing company during the Audits/Inspections of Supervisory Authorities such as Notified Body and Customer visits/audits.Qualification of manufacturers.Team Management. Show less



BD

• United States
• Architecture and Planning

• Senior Quality Leader

  • Oct 2017 - Jun 2019

  Implementing, improving and maintaining Quality Management System according to ISO 13485:2016 and 21 CFR 820. Quality Management Representative. Ensuring compliance to regulatory requirements such as ISO 13485:2016, 21CFR820. Establishing and improving processes. Ensuring compliance of processes such as CAPA, NCR, Risk Analysis, Software Validation, Management Review, Trainings with ISO 13485:2016 and 21CFR820. Change Management. Creation, verification and negotiation of the Quality Agreements. Building of Internal Audits process and its Management as Audit Program Manager. Internal auditors qualification. Carrying out Internal and External Audits (e.g. Suppliers). Participation during the Audits/Inspections of Supervisory Authorities such as Notified Body, FDA, Customer visits/audits and corporate audits. Team Management. Show less



PRO-PHARM S.C.

• Co-owner, Project Manager

  • Dec 2015 - Sep 2017

  Development, scheduling and supervising project activities for implemented products and Quality Management Systems. Implementing Quality Management Systems in accordance with the requirements of EN ISO 13485:2012, GDP, HACCP. Training staff on EN ISO 13485:2012, GDP, HACCP, legal requirements related to medical devices and internal auditing. Conducting internal and external audits. Supporting Clients during external supervisory authorities’ inspections. Preparing offers, negotiation of agreements and new Clients acquisition. Show less



USP Zdrowie

• Poland
• Pharmaceutical Manufacturing
• 300 - 400 Employee

• • Apr 2011 - Dec 2015

  Launching new food supplements, dietary foods for special medical purposes and medical devices to the market and maintaining their course of trade.Releasing non-medicinal products to the market.Qualification of manufacturers.Carrying out internal and external audits.Assessment and creation of technical and quality documentation, assessment of labelling.Preparation of quality agreements for non-medicinal products.Contacting external supervisory authorities.Co-creation of documentation for Quality Mangement System in accordance with the requirements of EN ISO 13485:2012 + AC:2012 and participation in the process of certification.Assesment of the Quality Management System documentation in accordence with the requirements of HACCP and GMP. Show less

• • Sep 2009 - Mar 2011

  Launching new food supplements to the market and maintaining their course of trade.Releasing food supplements to the market.Assessment and creation of the quality documentation, assessment of labelling.Preparation of quality agreements with Manufacturers.Contacting external supervisory authorities.Co-creation of documentation for Quality Mangement System in accordance with the requirements of HACCP and GMP.



Wojewódzka Stacja Sanitarno-Epidemiologiczna we Wrocławiu

• Junior Assistant

  • Nov 2007 - Jun 2009

  Validation of pesticide residue, heavy metals and mycotoxins assay methods. Carrying out daily analyses. Measuring equipment operation, research reporting. Administration of the Laboratory Department Food Safety System for Dolnoslaskie province. Co-creation of documentation for the Quality Management System in accordance with requirements of PN-EN ISO 17025:2005 at the Laboratory Department. Validation of pesticide residue, heavy metals and mycotoxins assay methods. Carrying out daily analyses. Measuring equipment operation, research reporting. Administration of the Laboratory Department Food Safety System for Dolnoslaskie province. Co-creation of documentation for the Quality Management System in accordance with requirements of PN-EN ISO 17025:2005 at the Laboratory Department.