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

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