Qualitätsmanager (m/w/x)
Core
Develop and implement quality management systems and standards for optomechanical and optoelectronic module components, specifically high-precision spherical optical systems for microscopy objectives.
Role type
Quality Manager (Regulated/Medical Devices)
Builds
High-precision optical systems for microscopy
Domain
Medical devices / Optoelectronics
Required skills
Quality management systems (ISO 13485, ISO 14971, MDSAP, IVDR, GMP), root cause analysis (8D, 5-Why, Ishikawa), risk analysis (FMEA), CAPA, SPC, validation and qualification, change management, internal auditing
Preferred skills
Experience in regulated environments or medical devices, practical experience as internal auditor, Chinese language skills
Technologies
8D, 5-Why, Ishikawa, FMEA, CAPA, SPC, ISO 13485, ISO 14971, MDSAP, IVDR, GMP
Responsibilities
Develop quality concepts and standards for new developments and production processes; analyze quality deviations and field failures to implement corrective actions; initiate and monitor quality measures; implement regulatory requirements into processes; develop and maintain quality documentation and standards; plan and conduct internal and external audits; support qualification, validation, and change management projects; collaborate with development, production, and supply chain teams.
Seniority
Mid-Senior, hands-on IC