Senior Quality Engineer (f/m/d) - Development

Job Description

• Interest in the development of complex (Electronic, Software and Mechanic) medical devices 
• Define and ensure 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
• Participation in risk analyses
• Creation / Release of documents for design verification / design validation
• Creation / Release  of Test Plans / Test Setups / Design of Experiment
• Review and release of changes to product design and manufacturing processes
• Contact person for customers and suppliers with regard to product quality (incl. Measures such as NC, CAPA, SCAR, etc.)
• Participation in the qualification / validation and evaluation of external production partners
• Subject Matter Expert for quality-related questions in the context of audits by customers

Qualifications

• A successfully completed engineering or scientific degree (mechanical engineering, physics or automation technology) or comparable qualification is desirable
• At least five years of practical experience as a quality engineer for medical devices
• Experienceed  in the FMEA method for medical devices
• Practical experience in the application of quality and problem-solving techniques
• In-depth knowledge of the interpretation and implementation of regulatory requirements for medical devices (MDR, EN ISO 14971, 21 CFR 820, EN 13485)
• Experience in the field of software quality assurance desirable
• Result-oriented, focused and structured way of working
• Proactive, communicative and solution-oriented personality
• Willingness and commitment to move things, ability to prioritize and make decisions
• Secure communication across all hierarchical levels as well as with customers and suppliers
• Willingness to travel (ca. 10%)
• English in spoken and written, German would be an advantage

Additional Information

We offer a challenging, international environment and the opportunity to actively contribute to the company and different teams with knowledge and engagement, and to develop personally. We also offer a modern workplace in a historic building, advanced and flexible working conditions as well as salaries according to performance and well-developed social benefits.

Interested? Please upload your complete application (letter of motivation, CV, job references, diplomas / certificates) by clicking on the "apply now" button. We look forward to reading from you.

Your contact person - For further information please contact Mr. René Ziegler, Senior Recruiting Specialist, +41 62 209 71 00