Quality Assurance Specialist

1 miesiąc temu


Łódź, Polska pixeltechnology Pełny etat

Opis stanowiska:

Pixel Technology poszukuje doświadczonego Specjalisty ds. Zapewnienia Jakości, który będzie odpowiedzialny za następujące zadania:

  • Pełnienie funkcji osoby odpowiedzialnej za zgodność regulacyjną (PRRC);
  • Wdrażanie wymagań MDR do systemu zarządzania jakością dla oprogramowania będącego wyrobem medycznym;
  • Tworzenie i aktualizacja dokumentacji technicznej;
  • Prowadzenie szkoleń z zakresu przepisów MDR i standardów jakości dla pracowników firmy;
  • Audytowanie i aktualizacja systemów zarządzania jakością zgodnie z normami EN ISO 13485 i 9001;
  • Śledzenie nowych publikacji, wytycznych oraz ustaw;
  • Wsparcie Zarządu firmy poprzez konsultacje.

Opis firmy:

Pixel Technology to polska firma z branży IT specjalizująca się w zastosowaniach informatyki w medycynie, w szczególności w rozwiązaniach przeznaczonych dla radiologii oraz obsłudze administracji publicznej w tym zakresie. Dostarczyliśmy rozwiązania do ponad 100 pracowni radiologicznych na terenie Polski. Firma istnieje na rynku od 1992 roku i zatrudnia wysokiej klasy specjalistów – tworząc oprogramowanie, świadcząc usługi wsparcia oraz prowadząc sprzedaż naszych systemów.

Wymagania:

  • Minimum 3-letnie doświadczenie w branży wyrobów medycznych, szczególnie w zakresie wdrażania wymagań MDR;
  • Doświadczenie w pracy z wyrobami medycznymi co najmniej klasy II;
  • Doświadczenie w zarządzaniu ryzykiem (FMEA) oraz w nadzorze nad wyrobami medycznymi;
  • Umiejętność audytowania systemów zgodnie z normami EN ISO 13485 i 9001;
  • Doświadczenie w pisaniu i weryfikowaniu dokumentacji technicznej wyrobu medycznego;
  • Umiejętność prowadzenia szkoleń i przekazywania wiedzy zespołom.

Oferujemy:

  • Udział w ciekawych i innowacyjnych projektach w firmie IT;
  • Możliwość wdrażania własnych pomysłów i rozwiązań;
  • Możliwość współpracy na UoP/B2B - Ty wybierasz;
  • Dedykowana ścieżka wdrożenia i rozwoju w strukturach firmy;
  • Tryb pracy hybrydowy lub zdalny;
  • Atrakcyjne wynagrodzenie uwzględniające Twoje doświadczenie i wiedzę;
  • Szeroki pakiet szkoleń wewnętrznych i zewnętrznych oraz kursów (w tym językowych);
  • Atrakcyjne benefity (Karta Multisport – w całości finansowana przez pracodawcę, opieka Medyczna – Allianz, Ubezpieczenie na życie);
  • Wspólne integracje w czasie pracy i po pracy.

Proces rekrutacyjny:

  • Etap 2: Wstępny akcept
  • Etap 3: Rozmowa telefoniczna
  • Etap 4: Rozmowa kwalifikacyjna
  • Etap 5: Oferta

Zachęcamy do aplikowania za pośrednictwem formularza aplikacyjnego.

Oczekujemy



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