Job Details

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


  • 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

About Gerresheimer

Gerresheimer is the global partner for pharmaceutics, biotech, healthcare, and cosmetics with a very broad product range for pharmaceutical and cosmetic packaging solutions and drug delivery systems. The company is an innovative solution provider from concept to delivery of the end product. Gerresheimer achieves its ambitious goals through a high level of innovative strength, industrial competence and concentration on quality and customer focus. In developing innovative and sustainable solutions, Gerresheimer relies on a comprehensive international network with numerous innovation and production centers in Europe, America and Asia. Gerresheimer produces close to its customers worldwide with around 11,000 employees and generated annual revenues in 2022 of EUR 1.8bn. With its products and solutions, Gerresheimer plays an essential role in people's health and well-being.

Equal rights

All applicants are considered without any regard to race, color, creed, religion, age, national origin, ancestry, ethnicity, gender, gender identity, gender expression, sexual orientation, marital status, veteran status, disability, genetic information, citizenship status or membership, or any other legally protected status.

Interested? Apply today!