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Quality Engineer for Medical Device Development

vor 3 Monaten

Solothurn, Schweiz Gerresheimer Vollzeit
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