Device Quality Assurance Professional
vor 2 Monaten
Job Overview
Gerresheimer is seeking a highly skilled Quality Assurance Specialist to join our team in the development of complex medical devices. As a key member of our quality team, you will be responsible for ensuring compliance with quality requirements for drug delivery systems and medical devices in development projects.
Key Responsibilities
- Define and ensure compliance with quality requirements for drug delivery systems and medical devices in development projects.
- Ensure the conformity of our products and product documentation over the entire product life cycle – focus on development and industrialization – Design Control.
- Collaborate in risk analyses and creation/approval of documents for design verification/design validation.
- Release of Test Plans/Test Setups/Design of Experiment and review/approve changes to product design and manufacturing processes.
- Act as contact person for customers and suppliers regarding product quality (incl. measures such as NC, CAPA, SCAR, etc.).
- Collaborate in the equipment qualification/process validation and evaluation of external production partners.
- Act as contact person for quality-related questions in the context of audits by customers or authorities.
Requirements
- 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.
- 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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