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MED-EL Elektromedizinische Geräte GmbH

  • Pharma, Chemie und Medizintechnik
  • Fuerstenweg 77 a, 6020 Innsbruck, Österreich
  • http://www.medel.com
  • office@medel.com
  • +43577887788
  • ATU31722507
Anprechpartner/Anprechpartnerin
  • MED-EL Elektromedizinische Geräte mbH
  • jobs@medel.com

Computerized System Validation Associate (m/f/d)

MED-EL is a leading manufacturer of innovative medical devices for the treatment of various types and degrees of hearing loss. Our unique portfolio of implantable hearing solutions benefits thousands of individuals in more than 140 countries worldwide. With headquarters in Innsbruck, Austria, MED-EL has over 2,800 employees around the world.

Aufgaben

  • Collaborate with cross-functional teams including IT, Quality Assurance, and Operations to ensure successful documentation and validation of systems according to internal procedures

  • Ensure compliance with regulatory requirements such as FDA 21 CFR Part 11, GxP, and other relevant guidelines

  • Maintain validation documentation, review the risk assessments for new and existing computerized systems

  • Conduct periodic reviews and trigger the re-validation of systems as required

  • Stay current with industry trends, regulatory changes, and best practices in computerized system validation

Qualifikation

  • Knowledge of regulatory requirements and guidelines, or certification (FDA 21 CFR Part 11, GxP, etc.) would be a benefit

  • Previous work experience in Computerized System Validation within a regulated industry (e.g., pharmaceuticals, biotechnology, medical devices) would be an advantage

  • MS Office proficiency and good general computer skills

  • Good organizational skills, be self-motivated and have a detail-orientated approach

  • Good communication skills in written and spoken English. German skills are a plus

Externer Link
https://jobs.medel.com/EN/open-position/QA_22501/online
Gehalt
Mindestgehalt pro Monat laut Kollektivvertrag:
3113 €
Ungefähres Jahresgehalt abhängig von der Qualifikation:
37361 €
Weitere Leistungen

Central Location

Employee Discounts

Flexible Hours

International Environment

Onboarding

Workplace Well-Being

Chiffre:
6452
Beschäftigungsart:
Vollzeit
Position im Unternehmen:
Berufserfahrung
Niveau Schul-/Studienabschluss:
Berufsfeld:
Unbekannt
Befristung:
Unbefristet
Erwarteter Arbeitsbeginn:
Sobald als möglich
Veröffentlicht:
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