Quality Engineer– Development Medical Devices
Solothurnerstrasse 235, Switzerland | Olten | Full-time
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
- Design Control for Medical Devices is where you have your knowledge
- Work as a lead with project manager topics for a small cross-functional team
- Ensuring the conformity of our products and product documentation over the entire product life cycle – focus on development
- Participation in risk analyses
- Creation / Release of documents for design verification / design validation in Cross-Functional Team
- 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 equipment qualification / process 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 three years of practical experience in design control for medical devices with Quality focus
- Experienced in the FMEA method for medical devices
- Practical experience in the application of quality and problem-solving techniques
- 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, planing 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
