Job Description

Project

: For our client, a large diagnostics company in Rotkreuz, Zug, we are looking for a

qualified Quality Assurance Manager in the field of Q&V (m/f/d)

Background:

We have a vacancy in our QA team for qualification and validation. The

customer base includes production and R&D units as well as post-market departments that use validated or qualified systems in the field of medical technology.

The perfect candidate

We are looking for a strong personality who either has many years of experience in the field of CSV (Computerized

System Validation) and/or extensive experience in the field of qualification, together with

excellent learning skills. Candidates who have previously worked exclusively in the field of quality assurance

must be able to demonstrate strong technical expertise in the aforementioned technical areas

Working in quality assurance requires excellent communication and negotiation skills in order 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 these in close cooperation with customers.

Tasks & responsibilities:

- In collaboration with the CSV validation teams and/or equipment qualification teams:

Providing advice on the creation of CSV validation plans and/or qualification plans Approving plans and reports, as well as all other relevant documents Approval of GxP changes or deviations in accordance with global processes - Detailed impact analysis on local processes in the event of changes to the global quality management system Preparation and coverage of QA aspects in ISO13485 audits

Must-haves:

Degree in a technical or scientific field At least 3 years of CSV validation experience in the medtech sector (ISO 13485) and/or experience in equipment qualification/management and calibration, combined with strong learning skills Experience in quality assurance is an advantage Strong personality who can assert themselves in discussions Knowledge of GSuite and MS Office Very good German and English skills are required

Nice to haves:

Strong interest and/or knowledge in the field of artificial intelligence SAP knowledge is an advantage

Reference No.: 924550

Role: Quality Assurance Manager in Q&V (m/f/d)

Industry: Pharmaceuticals

Location: Rotkreuz

Workload: 100%

Start: January 1, 2026 (start date: March 1, 2026)

Duration: 12+ months

Application deadline: 12/11/2025

Job Type: 100%

Work Location: On the road