Quality Assurance Specialist
1 miesiąc temu
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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