Overview
Quality Engineer Medical Device Development CDMO Jobs in Sandhubel, Switzerland at Gerresheimer AG
Position: Â Quality Engineer for Medical Device Development CDMO (m/f/d)
Location: Sandhubel
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)
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 12,000 employees and generated annual revenues in 2023 of around EUR 2bn. With its products and solutions, Gerresheimer plays an essential role in people’s health and well-being.
Equal rights
We commit to an
inclusive
recruitment process and equality of opportunity for all our job applicants. All applicants are considered without any regard to color, creed, religion, gender, gender identity, gender expression, sexual orientation, marital status, veteran status, disability, genetic information, citizenship status or membership, or any other legally protected status. Preference is given to hiring people with disabilities.
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Title: Quality Engineer Medical Device Development CDMO
Company: Gerresheimer AG
Location: Sandhubel, Switzerland
Category: Engineering, Quality Assurance – QA/QC
