Experience

AioCare

• Poland
• Medical Device
• 1 - 100 Employee

• Chief Operating Officer

  • Sep 2021 - Present

• Head of Quality, Regulatory & Operations

  • Jan 2021 - Present



MEDICON Lukasz Kurzatkowski

• Poland
• Medical Equipment Manufacturing

• Founder | Consultant | Expert | Auditor |

  • Jan 2014 - Present

  Inspirations for the foundation MEDICON in 2014 was mainly coordination of the activities I have had so far and I have now within my interest areas.A multitude of projects I have been and I'm still involved giving me possibility to work with people from quality, continuous improvement, operations, manufacturing and medical devices businesses.Experienced with Medical Devices industry within several positions in medical devices manufacturers and several years as ISO Auditor and Expert in Certification Body. Since 2006 I cooperate with medical devices manufacturers and since 2010 complementarily with certification body.I'm continuously looking for cooperation opportunities within Medical Devices industry, where I can work within contract cooperation which was and is a complementary to the actual positions I hold for medical device manufacturers.My experience is based on multiple aspects related to operations management, manufacturing management, general quality, continuous improvement, global manufacturing and repairs structure, green field projects in EMEA, APAC and Americas.Quality and manufacturing within medical devices industry are my specializations, almost from the beginning of my professional work:- Quality Management Systems complied with ISO 9001- Quality Management Systems complied with ISO 13485- Medical Devices Directive 93/42/EEC- FDA 21 CFR 820- several types of audits including internal, external, supplier’s audits and FDA inspectionsOn top of my experience from several years work with medical device manufacturers and cooperation with Certification Body TüV Nord I have also knowledge related to several processes required within medical devices industry like risk analyze ISO14971, guidelines for auditing management systems ISO 19011 and application of usability engineering to medical devices EN 62366.



ACRISON Business Solutions

• Poland
• Business Consulting and Services

• Founder | Consultant | Expert |

  • Mar 2020 - Present



LSJ Human Resources Group

• Poland
• Staffing and Recruiting
• 1 - 100 Employee

• Business Partner

  • Aug 2020 - Present



Braster S.A.

• Poland
• Medical Device
• 1 - 100 Employee

• Quality Management Representative

  • Oct 2020 - Present



TUV NORD Polska

• Poland
• Business Consulting and Services
• 1 - 100 Employee

• Lead Auditor | Expert | Medical Devices

  • Mar 2010 - Present

  Lead Auditor in TüV Nord Certifiation Body. ISO13485 and ISO9001 Quality Management Systems and Medical Devices Expert. Lead Auditor in TüV Nord Certifiation Body. ISO13485 and ISO9001 Quality Management Systems and Medical Devices Expert.



TQMsoft

• Poland
• Professional Training and Coaching
• 1 - 100 Employee

• Trainer | Consultant | Expert | Auditor

  • Jan 2020 - Present

  * Medical Devices* ISO 13485* ISO 14971* ISO 62366* Quality Management System* Technical Documentation* Regulatory Requirements* Quality Assurance* Quality Control* Design Tranfer* Industralization* Manufacturing* Processes* Servicing and Repairs* Complaints Handling * Medical Devices* ISO 13485* ISO 14971* ISO 62366* Quality Management System* Technical Documentation* Regulatory Requirements* Quality Assurance* Quality Control* Design Tranfer* Industralization* Manufacturing* Processes* Servicing and Repairs* Complaints Handling



Incert Systemy Zarządzania

• Poland
• Professional Training and Coaching
• 1 - 100 Employee

• Trainer | Consultant | Expert | Auditor

  • Jun 2020 - Present



3Shape

• Denmark
• Medical Device
• 700 & Above Employee

• General Manager, Global Operations Development

  • Mar 2018 - Apr 2020

  General Manager, Global Operations Development - management of Global Operations of 3Shape Group through 3Shape facilities in Poland, U.S and China and Global Service&Repairs through Poland, U.S., China, Japan, Korea, Brazil and Worldwide Partners.Areas/processes of responsibility:• Operations - Production - Production Master Data Administration - Lean Manufacturing• Quality&Production Engineering - Quality Assurance and Process Engineering - Incoming and Outgoing Inspection - Production Engineering - Design Transfer Projects• R&D Support Center• Global Service&Repairs (Poland, U.S., China, Japan, Korea, Brazil and Worldwide Partners)• Quality Management System based on ISO13485/FDA 21 CFR 820/ GMP ChinaClose cooperation with R&D Departments in Denmark, Italy and Ukraine and Business Development Offices in Europe, Americas and APAC.Management Board Member• Define Strategy and Budget for Global 3Shape Operations within 3Shape Group.• Day2Day management of the facilities in Poland, China and U.S.Development with 3Shape:• 2018, March as General Manager, Global Operations Development• 2016, January as Operations Director• 2014, January as Director Quality&Production Engineering• 2011, June as Management Board Member of 3Shape Poland• 2010, April as Quality&Production Engineering Manager

• Operations Director

  • Apr 2010 - Mar 2018

  Former positions:2016, January – 2018, March as Operations Director2014, January – 2016, January as Director Quality&Production Engineering2011, June as Management Board Member of 3Shape Poland2010, April joined 3Shape as Quality&Production Engineering ManagerOperations Director - management of operations activities of 3Shape Poland Manufacturing and Global Service&Repairs Network in Poland, China and U.S.Areas/processes of responsibility:• Operations – production, production master data and Lean Manufacturing• Quality&Production Engineering including quality assurance, production and process engineering, incoming and outgoing inspection, design transfer• R&D Support Center• Procurement, Planning and Warehouse management• Global Repairs&Service• Quality Management System based on ISO9001, ISO13485 and FDA 21 CFR 820• Active participation in internal and external audits and inspection including certification bodies, suppliers and FDA (U.S.) and KFDA (Kora).Close cooperation with Departments in Denmark and Ukraine and Business Development Offices in Europe, Americas and APAC.Management Board MemberDefine Strategy and Budget for operations part of organization within 3Shape Group and 3Shape Poland.Day2Day management of the facility in Poland.



Private Education Center "Scholar"

• Teacher/Lecturer Computer Science

  • Sep 2007 - Sep 2010

  Teacher: Information Technology; Processing information; Popularization of information; Networks and Operating Systems; Economics and Computer science. Teacher: Information Technology; Processing information; Popularization of information; Networks and Operating Systems; Economics and Computer science.



Demant Szczecin

• Poland
• Medical Equipment Manufacturing
• 1 - 100 Employee

• Management Systems Coordinator (started as Quality Management System Engineer)

  • Jan 2008 - Apr 2010

  Coordination of Management Systems on company level (Strategy, Business Plan, coordination of drawing up and completion of Company Strategy); Implementation of Quality Management System according to ISO9001:2008 and ISO13485:2003; Internal and external audits; Coordination of internal auditors group. Supervising over corrective, preventive and improvement actions; Trainings of Quality Management System; Coordinating the work of particular departments according to Quality Management System; Drafting, implementing and supervising procedures; Control of documents; Control of Quality Manual. The internal auditor ISO9001, ISO14001 and ISO13485.



Sonion

• Denmark
• Appliances, Electrical, and Electronics Manufacturing
• 300 - 400 Employee

• Calibration and Measurement Engineer

  • Feb 2007 - May 2008

  Supervision of measuring equipment; Internal and external calibrations of measuring equipment; Calibration documentation. Purchasing measuring equipment. Measuring parts of machines and production components. Administrating calibration equipment data base. The Internal auditor of Quality Management System ISO 9001, ISO14001 and ISO13485. Implementation of Quality Management System according to ISO13485.

• Data Base Administrator

  • Jun 2006 - Feb 2007

  Administrating of data base. Creating statements and production statistics. Internal audits ISO 9001 and ISO 14001. Implementation of corrective, preventive and improvement actions.