Qualitätsingenieur (w/m/d) – Technik und Verfahren
Core
Lead validation and qualification of manufacturing equipment and processes to ensure product quality and regulatory compliance in a medical device production environment.
Role type
Quality Engineer (Manufacturing/Validation)
Builds
Validated and qualified manufacturing processes and equipment for surgical instruments, implants, and suture materials
Domain
Medical Devices / Surgical Instruments / Manufacturing
Required skills
Validation and qualification of manufacturing processes, Statistical analysis, Process stabilization, Regulatory compliance knowledge, Cross-functional project leadership, Production environment experience
Preferred skills
Cleaning and packaging validation experience, Radiation sterilization knowledge
Technologies
Statistical software, Manufacturing execution systems
Responsibilities
Perform independent validations and qualifications of equipment and processes, Document and statistically analyze validation results, Ensure adherence to production and quality specifications on-site, Lead or support cross-functional projects, Act as the point of contact for quality and technical topics, Collaborate with production to identify efficiency potentials