Software Quality & Compliance Engineer (w/m/d)
Hybrid
Core
Ensure software and hardware compliance with the Cyber Resilience Act and medical device regulations for Analytik Jena's analysis systems.
Role type
Compliance engineer (software & embedded systems)
Builds
Compliance governance frameworks and audit readiness for medical analysis systems
Domain
Medical technology / Analytical instrumentation
Required skills
Cyber Resilience Act (CRA) knowledge, ISO 14971, IEC 62304, IEC 62443, GAMP 5, embedded systems, risk analysis, audit preparation
Preferred skills
None stated
Technologies
None stated
Responsibilities
Manage Cyber Compliance Governance per Cyber Resilience Act, oversee Software Quality Assurance and lifecycle monitoring, monitor Hardware/Firmware/Embedded Compliance, moderate risk analyses, prepare for internal and external audits
Seniority
Mid-level, individual contributor