Quality Engineer

Job Description

• 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

Qualifications

• Knowledge as obtained by technical study or equivalent technical education (e.g. mechanical technician, injection molding technician) with professional experience in the medical/pharmaceutical industry for at least 5 years Solid professional experience in the field of Quality Engineering or Quality Management
• Solid office software experience (SAP, MS Excel, MS Word, MS Powerpoint) (Advanced Level)
• Professional knowledge of applicable standards (e.g. ISO 13485, ISO 15378, 21 CFR 820, ISO 14971)
• Solid knowledge of statistical / QM methods (Professional Level)
• Performance and design motivation
• Action orientation, conscientiousness and flexibility
• Sensitivity and sociability
• Sociability and team orientation
• Emotional stability, resilience and self-confidence
• Fluent written and spoken English (A2 / B1)
• Good analytical competence; experience in systematic problem-solving Techniques (e.g. KT, Six Sigma, Fault-Tree Analysis)
• Good knowledge of moderation and presentation techniques
• Solid structured way of working

Additional Information

All your information will be kept confidential according to EEO guidelines.