Quality systems and operations for medical devices
Regulatory compliance in medical device service and repair
Multi-site global quality support
The role supports multiple workstreams focused on implementing Johnson & Johnson standards compliance for Abiomed field service and repair operations globally
Job Summary
The role supports multiple workstreams focused on implementing Johnson & Johnson standards compliance for Abiomed field service and repair operations globally.
The incumbent performs quality-related operational activities including escalation, non-conformance, CAPA, change control, and distributor control processes across Europe, Middle East, Africa, and indirectly other regions.
This position requires strong communication skills, the ability to build consensus without line authority, and a high tolerance for ambiguity in a complex global environment.
Matching Summary
The role supports multiple workstreams focused on implementing Johnson & Johnson standards compliance for Abiomed field service and repair operations globally.
Skills & Requirements
Must-have
Quality systems and operations for medical devices
Regulatory compliance in medical device service and repair
Multi-site global quality support
Change control and CAPA management
Audit and inspection management
Fluent in German and English
Nice-to-have
Six Sigma methodology
Computer System Validation knowledge
Strong collaboration and influence skills
Strategic and analytical thinking
Hands-on operational orientation
Conflict resolution and team building
Key Requirements
5+ years in highly regulated industry
Bachelor’s degree in engineering or scientific discipline
Experience with medical device manufacturing and service
Experience supporting multi-site global organizations