Quality Engineer for Medical Device Development (m/f/d), Olten
Client:
Gerresheimer
Location:
Olten
Job Reference:
39ab263f1995
Job Views:
10
Posted:
21.01.2025
Expiry Date:
07.03.2025
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)
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