Quality Engineer- Development Medical Devices

Quality Engineer- Development Medical Devices

We are on an exceptional exciting journey as we take an active role in creating the future of the digital healthcare ecosystem. As a key function within our team you will decisively contribute to the way chronic diseases are managed by taking advantage of the latest technological advances. If you are experienced in the field of market access strategies and bring a fresh mind with new ideas on how to bring better quality of life to patients, we are happy to offer you a place where you get the independence to creatively contribute to the future of healthcare.

As a listed MDAX company, Gerresheimer is a leading global partner to the healthcare and cosmetics industries. We generate sales of over 1.8 billion euros and are represented worldwide with about 10,000 employees. You will join a newly created digital innovation team and take the lead on the commercialization strategies for our innovative digital health solutions.

www.gerresheimer.com

• 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