Młodszy/a Inżynier/ka Jakości Q&V
Core
Creating and updating qualification and validation documentation (protocols, reports, risk analyses) and supporting change processes in a medical device manufacturing environment.
Role type
Junior Quality & Validation Engineer
Builds
Qualification and validation documentation for medical devices
Domain
Medical device manufacturing / Quality Assurance
Required skills
Analytical problem solving, Validation methodologies, Test methods knowledge, MS Office, Risk assessment, Non-conformance analysis, Corrective and preventive actions (CAPA), Project meetings participation
Preferred skills
Statistical tools, English (B2)
Responsibilities
Create and update qualification and validation documentation, Validate test methods, Support change processes affecting qualification status, Support sterilization processes, Participate in project meetings, Support non-conformance analysis, Participate in quality problem analysis (5Why, 8D, Ishikawa), Monitor corrective and preventive actions, Oversee validation and qualification activities in projects, Collaborate with internal departments and service providers.
Seniority
Junior, hands-on IC