QA Engineer
Core
Ensure new processes, equipment, and products are introduced in compliance with quality and regulatory requirements for manufacturing expansion.
Role type
Quality Assurance Engineer (Manufacturing/Validation)
Builds
Manufacturing processes and equipment for the biopharmaceutical industry
Domain
Life Sciences / Regulated Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Validation activities, Risk assessments, Change control, CAPA management, Deviation investigation, Root cause analysis, Internal audits, Supplier qualification, QMS maintenance
Preferred skills
Dutch language proficiency
Technologies
ISO 9001, GMP
Responsibilities
Support qualification and validation activities for new equipment and manufacturing processes; Review and approve validation and quality documentation; Lead risk assessments and support change control activities; Investigate deviations, non-conformances, customer complaints, and CAPAs; Conduct root cause investigations and support corrective actions; Support internal audits and supplier qualification activities; Maintain and improve Quality Management System (QMS) processes.
Seniority
Mid-level, hands-on IC
