Quality Engineer (m/w/d)
Core
Ensure quality and compliance in the manufacturing of medical devices, including product releases, root-cause analysis, and change management.
Role type
Quality Engineer (Medical Devices Manufacturing)
Builds
Medical device manufacturing processes and products
Domain
Medical Technology / Healthcare Manufacturing
Required skills
Quality Management Systems, Regulatory Affairs, Root-Cause Analysis, CAPA, Change Management, Nonconformity Management, Audit Support, Validation Documentation, SAP, Trackwise, Microsoft Office
Preferred skills
Injection molding, automated assembly, metal processing, ISO 13485, ISO 14971, MDSAP, MDR
Technologies
SAP S/4HANA, Trackwise, Microsoft Office
Responsibilities
Plan, establish, and monitor quality assurance measures for medical device manufacturing; Ensure implementation of quality requirements, standards, and laws; Execute quality measures regarding production, including product releases, root-cause analysis, change and complaint management, handling nonconformities and CAPAs; Review and approve qualification and validation documents; Participate in internal, customer, and regulatory audits
Seniority
Mid-level, hands-on IC