Donaldson is committed to solving the world’s most complex filtration challenges. Together, we make cool things. As an established technology and innovation leader, we are continuously evolving to meet the filtration needs of our changing world. Join a culture of collaboration and innovation that matters and a chance to learn, effect change, and make meaningful contributions at work and in communities.
Join a growing international biotech organization at the heart of innovation in bioreactors and control systems. As a Quality Assurance Specialist, you’ll contribute to product integrity, continuous improvement, and operational excellence.
What’s in it for you
1. A unique opportunity to work across multiple areas of QA: production, warehouse, validation, and supplier/customer interface—broader than most QA roles.
2. A dynamic and supportive team culture where your initiative, input, and hands-on mindset can directly shape daily operations and product quality.
3. Long-term contract with a competitive salary, health insurance, pension plan, meal vouchers, and growth opportunities in a fast-evolving organization.
Role Responsibilities
4. Support the release of high-quality products (single-use bioreactors, manifolds, and controllers) by reviewing batch records and ensuring quality standards are met.
5. Oversee cleanroom operations, incoming inspections, and quality control activities, ensuring compliance with internal procedures and regulatory expectations.
6. Coordinate and follow up on quality events (deviations, document reviews, change requests, CAPA), providing guidance across production, logistics, and maintenance.
7. Contribute to project workstreams by supporting validation activities (DQ, FMEA, IOQ, PQ) and approving specifications and drawings.
8. Support internal audits and quality system documentation updates while helping teams understand and apply quality processes.
9. Collaborate with cross-functional stakeholders to drive continuous improvements and deliver practical solutions in a dynamic production environment.
Minimum Qualifications
10. Fluency in both French and English (written and spoken).
11. Prior experience with single-use technologies or qualification of hardware/software equipment in a regulated environment.
12. Strong understanding of quality systems (non-conformities, GMP practices, document control).
13. Ability to work independently, prioritize tasks, and adapt in a fast-paced setting.
14. Competency in Microsoft Office tools, especially Excel, Word, and PowerPoint.
Preferred Qualifications
15. Master's degree in a scientific or engineering discipline.
16. 5+ years of experience in a quality, production, or validation role in a GxP-regulated environment (e.g., biotech, pharma, or medical devices).