Mitarbeiter / Bürosachbearbeiter für die Qualitätssicherung (w/m/d)
Core
Office Quality Assurance Specialist supporting a Contract Manufacturing Organization (CDMO) in medical devices and pharma by managing documentation, quality decisions, and audit support.
Role type
Quality Assurance Office Specialist (CDMO)
Builds
Medical device and pharmaceutical production documentation and quality records
Domain
Medical Devices / Pharma / Quality Assurance
Required skills
Document review, Quality release decisions, Deviation management, Audit support, ERP system usage, Document management, KPI monitoring, Data archiving
Preferred skills
Chemical-technical background, Lab experience, Analytical understanding, Self-organization
Technologies
ERP systems, Document Management Systems (DMS), MS Office, Windows applications
Responsibilities
Review production records and analysis results; Approve/reject raw materials and products; Manage deviations and non-conforming products; Support internal and external audits; Maintain quality KPIs and report OOS events; Archive quality documents and samples
Seniority
Entry-level to Mid-level