Quality Assurance and QMS Expert (Medical Devices)
Prismond Group SA
Zurich, Switzerland
vor 1 Tg.

Role & Responsibilities

In your role as a Prismond Quality Assurance / QMS ISO 13485 Expert, you are supporting our local clients and team by :

  • Implementation and continuous improvement of the Quality Management System in order to ensure current regulatory requirements
  • Preparation and implementation of internal policies and SOPs
  • Handling of Change Control Requests, Non-Conformities and CAPAs, ensuring their adequate and timely closure
  • Support audit readiness (ISO 13485 and FDA 21 CFR 820)
  • Conducting internal audits (Self inspections and supplier audits)
  • Draft and negotiation of Quality Agreements
  • Review and formal approval of technical reports and / or batch records
  • Providing internal and external (QMS) trainings and coachings
  • Position Requirements

  • University degree in Quality, Engineering, Sciences or another relevant discipline
  • At least 2-3 years in QA environment within Medical Device, Pharma or Biotech industry
  • Strong knowledge of European and US regulations, guidelines and standards such as ISO 13485, EC Directive 93 / 42 / EEC, FDA 21CFR part 11, ISO 9001, ICH etc.
  • Broad working knowledge of QMS ISO 13485 regulations; basic understanding of medical device manufacturing process
  • Analytical and structured working style; strong attention to detail
  • Ability to effectively work as part of a multidisciplinary, international team
  • Good verbal and written communication skills in English, German language is a plus
  • Bewerben
    Zu Favoriten hinzufügen
    Aus Favoriten entfernen
    Bewerben
    Meine Email
    Wenn Sie auf "Fortfahren" klicken, stimmen Sie zu, dass neuvoo Ihre persönliche Daten, die Sie in diesem Formular angegeben haben, sammelt und verarbeitet, um ein Neuvoo-Konto zu erstellen und Sie gemäß unserer Datenschutzerklärung per Email zu benachrichtigen. Sie können Ihre Zustimmung jederzeit widerrufen, indem Sie diesen Schritten folgen.
    Fortfahren
    Bewerbungsbogen