Quality Engineer (w/m/d)
Core
Ensure quality of medical implants by managing quality processes, systems, and audits throughout the product lifecycle.
Role type
Quality Engineer (Medical Devices)
Builds
Medical implants
Domain
Medical technology / Manufacturing
Required skills
CAPA management, PPAP processes, risk analysis (FMEA), statistical analysis (SPC, MSA), audit preparation, QMS maintenance, technical documentation review
Preferred skills
Minitab, MS Project, gap analysis, worst-case assessment
Technologies
MS Office, Minitab, MS Project
Responsibilities
Develop and maintain CAPA and complaint management systems; coordinate PPAP processes including drawing reviews and capability studies; create and evaluate risk analyses and GAP analyses; support internal and external audits; handle technical customer inquiries; maintain QMS and analyze quality KPIs; approve markings and quality documents; serve as technical contact for customers and suppliers
Seniority
Mid-level, hands-on IC
