Quality Assurance Manager (Qualification & Validation)
Jobdescription
For one of our clients, a world leader in in-vitro diagnostics, we are currently looking for a Quality Assurance Manager for Qualification & Validation.
General Information:
- Start date: January 2026
- Latest possible start date: March 2026
- Duration: until December 2026 with the possibility of extension
- Workplace: Rotkreuz
- Workload: 80-100%
- Remote/Home Office: Yes, 50% possible, can be increased temporarily by arrangement
- Working hours: Standard
- Department: DQOHE
- Team: 14 people
About the job:
The QA team for qualification and validation is looking for an additional Quality Assurance Manager. The clients include production and R&D units, as well as post-market departments that use validated or qualified systems in the medical technology sector.
The perfect candidate:
Our client is looking for a strong personality with either many years of experience in CSV (Computerized System Validation) and/or extensive experience in qualification, combined with excellent learning skills. Candidates who have previously worked exclusively in quality assurance must be able to demonstrate strong technical expertise in the aforementioned areas.
The role of Quality Assurance Specialist requires excellent communication and negotiation skills to advise and guide the validation/qualification teams. The candidate has a clear understanding of the relevant Q&V requirements in medical technology (according to ISO 13485) and can implement them in close collaboration with clients.
Tasks & Responsibilities:
In collaboration with the CSV validation teams and/or the equipment qualification teams:
- Advising on the creation of CSV validation plans and/or qualification plans
- Approval of plans and reports, as well as all other relevant documents
- Approval of GxP changes or deviations according to global processes
- Detailed impact analysis on local processes for changes in the global quality management system
- Preparation and coverage of QA aspects in ISO 13485 audits
Must Haves:
- Completed degree in a technical or scientific field
- Minimum 3 years of CSV validation experience in the medtech sector (ISO 13485) and/or experience in equipment qualification/management and calibration combined with a strong capacity for learning
- Experience in quality assurance is an advantage
- Strong personality with strong communication skills
- Knowledge of G Suite and MS Office
- Excellent German and English skills are required
Nice to haves:
- Strong interest in and/or knowledge of artificial intelligence
- SAP knowledge is an advantage
Ready to drive global diagnostics forward? Apply now and become an integral part of this innovative team! We are looking forward to receiving your application!
Application Submission Deadline: 12.11.2025
Walentyna Dobrowolska