Qualitätsmanager (m/w/x)
Core
Develop and implement quality management systems and standards for the production of high-precision optical systems used in microscopy objectives.
Role type
Quality Manager (Regulated/Medical Devices)
Builds
High-precision spherical optical systems for microscopy
Domain
Medical Devices / Optomechanics
Required skills
Quality management systems (ISO 13485, ISO 14971, MDSAP, IVDR, GMP), Root cause analysis (8D, 5-Why, Ishikawa), Risk analysis (FMEA), CAPA, SPC, Qualification and Validation, Change Management, Internal Auditing
Preferred skills
Experience in regulated environments, 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 production processes; Analyze quality deviations and field failures to implement corrective actions; Plan and conduct internal and external audits; Support qualification and validation of equipment and processes; Collaborate with cross-functional teams including R&D, Production, and Suppliers.
Seniority
Mid-Senior, hands-on IC