Quality Engineer for Medical Device Development

• Interest in the development of complex (electronic, software and mechanic) medical devices
• Defining and ensuring compliance with quality requirements for drug delivery systems and medical devices in development projects
• Ensuring the conformity of our products and product documentation over the entire product life cycle – focus on development and industrialization – Design Control
• Collaboration in risk analyses
• Creation / approval of documents for design verification / design validation
• Creation / Release of Test Plans / Test Setups / Design of Experiment
• Review and approve changes to product design and manufacturing processes
• Contact person for customers and suppliers regarding product quality (incl. measures such as NC, CAPA, SCAR, etc.)
• Collaboration in the equipment qualification / process validation and evaluation of external production partners
• Contact person for quality-related questions in the context of audits by customers or authorities

Requirements

• Completed technical or scientific education or equivalent
• Several years of experience in working in the field of medical technology products, pharmaceuticals and/or in-vitro diagnostics
• Practical experience in the risk management method for medical devices
• Practical experience in the application of quality and problem-solving techniques
• Knowledge in the interpretation and implementation of regulatory requirements for medical devices (MDR, EN ISO 14971, 21 CFR 820, EN 13485)
• Structured and result-oriented way of working
• Willingness to proactively participate and make things happen, ability to prioritize and make decisions
• Solution-oriented and communicative personality
• Confident in communication across all hierarchical levels, internally and with customers
• Willingness to travel (approx. 10%)
• Very good oral and written language skills in German (B2) and English (C1)