Product Quality Engineer
Core
Ensuring quality compliance and product conformity for medical devices, managing deviations, and coordinating validations.
Role type
Product Quality Engineer (Medical Devices)
Builds
Medical device products and manufacturing processes
Domain
Medical Technology / Healthcare Manufacturing
Required skills
Quality management systems (QMS), Change control, 8D reporting, CAPA management, Qualification and validation planning, FMEA, Statistical analysis, Regulatory standards (MDR, ISO 13485, 21 CFR 820, GMP), German (fluent), English (fluent)
Preferred skills
Injection molding experience, Minitab, Process methods
Responsibilities
Ensure compliance with quality requirements for medical devices and product conformity during changes; Manage deviations and changes independently; Create 8D reports and act as CAPA owner; Develop and coordinate qualification and validation plans; Plan and implement re-qualifications; Investigate product complaints; Coordinate FMEAs and statistical analysis; Participate in internal and external audits; Create requirement catalogs and control plans.
Seniority
Mid-level, hands-on IC