The Senior Specialist reviews and approves engineering changes ensuring full, correct, and regulatory compliant implementation
Job Summary
The Senior Specialist reviews and approves engineering changes ensuring full, correct, and regulatory compliant implementation.
They manage document control within the quality management system and moderate change and document review boards to ensure efficient decision-making.
The role involves close collaboration with quality, engineering, production teams, and international partners to drive continuous improvements in the QMS.
Matching Summary
The Senior Specialist reviews and approves engineering changes ensuring full, correct, and regulatory compliant implementation.
Skills & Requirements
Must-have
Engineering Change Requests approval
Quality Management System document control
Process and design change management
Regulatory compliance in change processes
International team collaboration
English and German language proficiency
Nice-to-have
Knowledge of ISO 13485, MDR, FDA QSR
Experience with Quality Metrics and Reporting
Moderation of cross-functional review boards
Continuous improvement in QMS
Hybrid or onsite work flexibility
Key Requirements
Completed degree in Engineering, Life Sciences, or Quality Management
2-3 years experience in Quality or Change Management in regulated industry
Experience with technical documentation and change processes