Qualitätsmanager (m/w/d)
Core
Develop and implement quality management systems and standards for optomechanical and optoelectronic module production, ensuring compliance with regulatory requirements and driving continuous process improvement.
Role type
Quality Manager (Regulated/Medical Devices)
Builds
High-precision spherical optical systems for microscopy objectives
Domain
Optics manufacturing / Medical Devices
Required skills
Quality management systems (QMS), Regulatory compliance (ISO 13485, IVDR, GMP), Root cause analysis (8D, 5-Why, Ishikawa), Risk management (FMEA, ISO 14971), Validation and Qualification, Change Management, Auditing, Statistical Process Control (SPC)
Preferred skills
Internal Auditor certification, 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 existing processes; Analyze quality deviations and field failures to implement corrective actions; Initiate and monitor quality measures and define testing strategies; Evaluate and implement new regulatory requirements into processes; Plan and conduct internal and external audits; Support qualification, validation, and change management activities.
Seniority
Mid-Senior, hands-on IC