Job Description

Execution of assigned quality tasks during product realization process according to the stage gate process 

Self-reliant planning and surveillance of Risk Management Activities for Medical Devices (ISO 14971, A-Risk Analysis; D-DMEA; P-FMEA)

Participation in Risk / FMEA assessments in alignment with risk management staff members Self-reliant coordination of quality-related matters with our customers

Self-reliant definition of Validation Strategy in accordance with regulatory and customer requirements following risk-based approach (documentation in VMP and CRS/PRS)

Self-reliant surveillance of validation activities in accordance with validation master plan, Product Specifications (e.g. CRS) and qualification / validation plans

Self-reliant definition of criteria for and execution of visual inspections of parts and assemblies in the field of qualification and validation activities.

Self-reliant planning and managing of (Product-) Design Verification Activities

Self-reliant definition of quality requirements for purchased parts and coordination with suppliers

Additional Information

All applicants are considered without any regard to color, creed, religion, gender, gender identity, gender expression, sexual orientation, marital status, veteran status, disability, genetic information, citizenship status or membership, or any other legally protected status. Preference is given to hiring people with disabilities.