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
Benefits
Corporate Benefits
Benefit from special conditions with various brands in fashion, technology, leisure and many more.
Food & drinks
We offer you free beverages and snacks.
Healthcare & pension
Your health and well-being is important to us. We offer fitness trainings, company pension plans and a group insurance.
Learning & development
According to the job and position, we make sure our employees get regular trainings and coaching to unleash their possibilities.
Mobile working
Mobile working and home office arrangements make our work routine more flexible.
Working environment
Creating a great place to work is essential for us, so we live up to our values teamwork, responsibility, integrity, bold innovation and excellence (TRIBE).
Note: Benefits might vary depending on the position.
