Mitarbeiter*in Qualitätssicherung (m/w/d)
Core
Operate and continuously improve the Quality Management System (QMS) to ensure reliable, compliant, and audit-ready processes for a genomics and diagnostics company.
Role type
Quality Assurance Specialist (QMS)
Builds
Quality Management System (QMS) aligned with ISO 9001
Domain
Life Sciences / Genomics / Diagnostics
Required skills
Quality Management Systems (QMS), ISO 9001, CAPA, Non-Conformance Management, Change Control, Document Management, Internal/External Audits, Supplier/Customer Quality, Data Analysis
Preferred skills
Experience in regulated environments, Continuous Improvement methodologies
Technologies
eQMS, ISO 9001
Responsibilities
Maintain and develop the QMS in line with ISO 9001; Manage deviations, Non-Conformances, CAPAs, and Change Controls; Prepare and accompany internal and external audits; Ensure training requirements and quality records are compliant; Support supplier and customer quality issues; Monitor quality data and trends to identify improvements.
Seniority
Mid-level, hands-on IC
