Izabela Osiecka

Biomedical Engineer/ QMS Representative at Higo Sense
  • Claim this Profile
Contact Information
Location
Warsaw, Mazowieckie, Poland, PL
Languages
  • angielski Limited working proficiency
  • polski Native or bilingual proficiency

Topline Score

Bio

Generated by
Topline AI

5.0

/5.0
/ Based on 1 ratings
  • (1)
  • (0)
  • (0)
  • (0)
  • (0)

Filter reviews by:

You need to have a working account to view this content. Click here to join now
Piotr Więckowski

I had been working with Iza for over one year during the development of the Higo telemedical device. She was responsible for the variety of tasks within the organization, focusing mainly on quality management system and legal and normative requirements. Iza is very ambitious, totally dedicated to her work and always cares about the quality of the things she's working on. She's not afraid to ask the right questions which leads to a thorough understanding of the topic for her and her interlocutors. She also has a rare ability to search for the more efficient solutions by dividing big problems into smaller pieces and investigating them step by step. Iza also loves to study new things and has an impressive learning curve. Adding the fact that she's also a very hardworking person, the outcome of her work has been always of the highest quality. Iza also cares about the team and is eager to help her colleagues. Besides, being a true professional at work, Iza is also a very warm person you can discuss literally any topic with. Whenever aiming for the highest quality of work, thoroughness and deep understanding of the topics, just hire Iza!

0

/5.0
/ Based on 0 ratings
  • (0)
  • (0)
  • (0)
  • (0)
  • (0)

Filter reviews by:

No reviews to display There are currently no reviews available.
You need to have a working account to view this content. Click here to join now

Credentials

  • Auditor Wewnętrzny Systemu Zarządzania Jakością Urządzeń Medycznych ISO 13485:2016
    BSI
    Dec, 2019
    - Sep, 2024
  • Kierownik ds Jakości i Auditor Wewnętrzny Systemu Zarządzania Jakością wg normy PN-EN ISO/IEC 17025:2005
    Incert Systemy Zarządzania
    May, 2014
    - Sep, 2024

Experience

    • Poland
    • Medical Equipment Manufacturing
    • 1 - 100 Employee
    • Biomedical Engineer/ QMS Representative
      • Jan 2019 - Present

      - defining and preparation of technical file of medical devices - maintenance, archiving and preparing QMS documentation - coordination of cooperation with the external authorities involved in the medical device certification process -monitoring changes in applicable standards and regulations; -assessment of biocompatibility of materials used to manufacture a medical device -supporting the R&D department in implementation of legal and normative requirements, verification and validation processes Show less

    • Poland
    • Investment Management
    • 1 - 100 Employee
    • Quality Intern
      • Jul 2018 - Dec 2018

      -supporting Project Manager in his activities -preparing presentations, reports -supporting CPM in his activities (assistance in preparing certification documents) -supporting Project Manager in his activities -preparing presentations, reports -supporting CPM in his activities (assistance in preparing certification documents)

    • Poland
    • Research Services
    • 1 - 100 Employee
    • Intern in Medical Product Certification Division
      • Jun 2018 - Jul 2018
    • Lab Trainee
      • Sep 2013 - Sep 2013
    • Lab trainee
      • Feb 2012 - Feb 2012

      - help with laboratory analysis - verification and supplementation of quality documentation - help with laboratory analysis - verification and supplementation of quality documentation

Education

  • Politechnika Warszawska
    PhD candidate, Inżynieria biomedyczna
    2014 - 2021
  • Politechnika Łódzka
    Magister inżynier (Mgr inż.), Technologia chemiczna
    2013 - 2014
  • Politechnika Łódzka
    Inżynier (Inż.), Chemia
    2009 - 2013

Community

You need to have a working account to view this content. Click here to join now