Engineer I, QA - (m/f/d) Part-time 50% (19.25 hours/week)
Core
Maintaining and continuously improving the Quality Management System (QMS) per ISO 9001:2015 standards.
Role type
Quality Management Engineer
Builds
Quality management processes and documentation for immunological detection systems
Domain
Life Sciences / Biotechnology / Quality Assurance
Deliverable
infrastructure
Required skills
ISO 9001:2015 knowledge, CAPA management, root cause analysis, FMEA, change management, validation support, risk analysis
Preferred skills
Experience in regulated environments, natural sciences background
Technologies
MS Office
Responsibilities
Maintain and develop the QMS, create and manage QM documents, support internal and external audits, handle deviations and CAPAs, participate in risk analysis and FMEA, support validation and qualification projects, contribute to continuous improvement processes
Seniority
Mid-level, hands-on IC
