Software Quality Assurance Engineer

Location: Eindhoven, North Brabant Salary: competitive
Sector: Engineering Type: contract

Are you an enthusiastic Software Quality Assurance Engineer with experience in validation of quality systems in the medical device industry?

A large international organization in Eindhoven is looking for a Software Quality Assurance Engineer for a project of at least one year.

We're hiring a Software Quality Assurance Engineer!

How your potential will be optimised:
This project will enable you to use your skills to:

* Enforce policies and procedures for all automated processes that interface and drive with the quality system.
* Support the development of the validation strategy from planning to retirement.
* Support the internal audits, and provide expertise during regulatory inspection.
* Provide support in development projects and changes to existing systems.
* Provide GxP-related QA oversight, with the focus on software validation.
* Provide guidance to personnel in their validation efforts, to ensure compliance.
* Advise technical personnel and management on regulatory compliance.

A track-record to fit in perfectly:
* 7 years' of experience in validation of computer systems and systems security.
* Working experience in a regulated industry (pharmaceuticals or medical devices).
* Knowledge of 21 CFR, ISO 13485, GAMP 5.
* Ability to interact with project teams, business leaders and executives (both verbal and written).
* Understanding how the FDA, notified bodies and other regulatory agencies conduct inspections.
* Able to execute multiple projects at the same time.

Apply now:
Apply now for the role of Software Quality Assurance Engineer and send your CV to Sjoerd Spoelstra via s.spoelstra(at) Please include an indication of your desired salary, your motivation and availability.

If you would like further information about this project or similar projects, call Sjoerd Spoelstra on 010-2069888.

Sthree Holland is acting as an Employment Business in relation to this vacancy.