Quality Engineer for Medical Device Development (m/f/d)
Solothurnerstrasse 235, Switzerland | Olten | Full-time
Job Description
Role
- 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
Qualifications
Profile
- 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)
Additional Information
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.