Staff Quality Engineer (Manufacturing Site, Grecia)
Core
Uphold efficiency of the Quality Assurance department and ensure compliance with Quality Management Systems (QMS) and regulatory standards (FDA GMP, ISO 13485, MDSAP) to safeguard product and process quality.
Role type
Staff Quality Engineer
Builds
Quality Management System compliance and product/process quality
Domain
Medical Device Manufacturing / Regulatory Compliance
Deliverable
client delivery
Required skills
Risk assessment, CAPA management, statistical sampling, audit support, non-conformance resolution, QMS compliance, trend analysis
Preferred skills
None stated
Technologies
Electronic Quality Management systems
Responsibilities
Escalate and resolve quality issues between departments; Coordinate with production and engineering to maintain quality standards; Ensure containment of non-conforming products; Investigate quality issues and perform risk assessments; Monitor and trend quality data; Interpret Risk Management Files (FMEA); Evaluate changes to electronic QMS; Support internal and external audits
Seniority
Staff, self-sufficient IC