Quality Specialist (9001 Certificated) Analytical Instruments
Core
Maintain regulatory compliance and drive continuous improvement of quality systems for analytical instruments across commercial sites in EMEA.
Role type
Quality and Compliance Specialist
Builds
Quality management systems, certifications (ISO 9001/17025), and compliance frameworks for Instrument & Enterprise Services.
Domain
Life Sciences / Analytical Instruments / Quality Assurance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
ISO standards (9001/13485/17025), GMP/GLP regulations, IQ/OQ/PQ validation, CAPA processes, deviation management, change control, internal auditing, root cause analysis, statistical analysis, technical writing, SharePoint, document control systems
Preferred skills
Life Sciences, Engineering, Chemistry, Biology, Dutch, German
Technologies
SharePoint, Microsoft Teams, Document Control Systems
Responsibilities
Investigate quality issues, conduct audits, manage nonconformities and complaints, implement corrective actions, maintain certifications, coordinate quality reporting, author SOPs and investigation reports
Seniority
Mid-level, hands-on IC