Quality Manager for Computerized System Validation.

21. Januar 2023


We are looking for an additional Infrastructure Partnering Team member in the area of Computerized System Validation (CSV).
The position offers a close collaboration with our internal business partners in Global Customer Support, and Information Solutions but also interaction with Integrated Informatics (IT). Together with our partners, we develop, derive, and approve validation strategies based on cutting-edge technology (like artificial intelligence).

The perfect candidate serves as an agile Quality Manager and enables our customers to deliver the required validation artifacts quickly and at the required quality standards. He/she performs document reviews/approvals in an independent, agile and holistic manner and has a profound understanding of our global quality management system. The perfect candidate can guide our IT colleagues when it comes to the needs of our quality management system.

General Information:

  • Start date: ASAP
  • Extension: possible
  • Workplace: Rotkreuz
  • Workload: 80 – 100%
  • Remote/Home Office: possible, load needs to be discussed

Tasks & Responsibilities:

  • Act as an independent Quality Partner for our qualification & validation business teams (in particular for computerized system validation CSV)
  • Enable our business partners to develop and execute compliant and efficient validation strategies based on our global quality management system
  • Perform comprehensive and independent feedback, review, and approval of all validation and qualification artifacts involved in the system life cycle
  • Based on a deep understanding of our global quality management system: act as an ambassador of the global quality assurance processes and thereby enable our business partners to deliver high-class medical products
  • Shape, live, and defend our global quality management system

Must Haves:

  • Min. technical or scientific degree (FH/HF/University degree) or completed education in a technical profession (e.g. Computer Science, electrical engineering or IT)
  • Min. 3-5 years of practical expertise in the area of qualification and validation
  • Experience in a GxP-regulated environment
  • Experience with quality management in the area of medical devices or in vitro Diagnostics (based on ISO 13485, FDA, and Quality Systems Regulations)
  • Fluency in English spoken and written
  • German at least B1. Level (no certification needed)
  • Pragmatically achieving the highest quality standards while keeping stakeholders happy is your passion
  • Good judgment, negotiation, and communication skills, ability to prioritize tasks
  • Autonomous, flexible, agile, and open-minded team player with the ability to assert yourself

We are looking forward to receiving your application!

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