Conformity Engineer Embedded Software (m/w/d)
Core
Ensuring regulatory compliance and quality standards for embedded software products within the ZEISS ecosystem.
Role type
Conformity Engineer (Embedded Software)
Builds
Compliance documentation and specifications for embedded software products
Domain
Medical Technology / Embedded Systems / Regulatory Affairs
Deliverable
dashboards & analysis
Required skills
Knowledge of relevant norms and regulations (e.g., ISO 25010), Product conformity assessment, Technical documentation management, Software development lifecycle understanding, Risk analysis, IT security concepts, SAP system usage
Preferred skills
Experience in Quality Management, Regulatory Affairs, Verification & Validation
Responsibilities
Research applicable norms, guidelines, and safety regulations; Identify and evaluate company policies and customer-specific standards; Lead conformity assessments for ZEISS products; Verify CRA compliance of assigned products; Maintain and manage CRA compliance documentation in SAP; Derive and document compliance requirements for external service providers and suppliers; Collaborate with Procurement, R&D, and Quality Assurance to ensure supplier adherence
Seniority
Mid-level (3–5 years experience)