Quality Engineer
Quality Engineer
Full-time | On-site | Permanent | Netherlands
We're currently partnering with a global leader in life sciences and health care innovation to find a Quality Engineer who's ready to make an impact in the Life Science sector.
This is an exciting opportunity to be a key quality lead on plant-wide projects and cutting-edge R&D initiatives, playing a central role in validations, sterility assurance, and customer-facing quality activities.
In this role, you will:
* Lead/support the implementation of Process Flows, Control Plans, FMEAs, and validations
* Review and approve validation documents for gamma irradiation and sterility claims
* Coordinate external lab activities and method development
* Serve as the plant's Quality Lead on cross-functional and R&D projects
* Manage quality responses for customer audits, certifications, and surveys
We're looking for:
Master's degree in a life sciences or technical field (Bio, Chemical, Pharma, etc.)
3+ years of experience in medical devices or a regulated industry
Fluent in English and Dutch
Knowledge of ISO 9001 / 13485, strong analytical and validation experience
Bonus if you bring:
* QMS experience
* Root cause analysis know-how
* A creative, data-driven problem-solving mindset