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Senior Quality Assurance Specialist for Medical Devices
vor 2 Monaten
Job Description
At Gerresheimer, we seek a dedicated Senior Quality Assurance Specialist for Medical Devices to join our team.
As a key member, you will be responsible for ensuring the conformity of our products and product documentation throughout the entire product life cycle, with a focus on development and industrialization, Design Control.
Key Responsibilities:
- Collaborate in the development of complex (electronic, software, and mechanic) medical devices.
- Develop and ensure compliance with quality requirements for drug delivery systems and medical devices in development projects.
- Review and approve changes to product design and manufacturing processes.
- Serve as the primary contact for customers and suppliers regarding product quality, including measures such as NC, CAPA, SCAR, etc.
- Collaborate in the equipment qualification and process validation of external production partners.
- Provide expert guidance on 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.
- Knowledge of the interpretation and implementation of regulatory requirements for medical devices (MDR, EN ISO 14971, 21 CFR 820, EN 13485).
- Strong problem-solving and communication skills, with ability to work in a structured and result-oriented manner.
- Proficient in German (B2) and English (C1).
What We Offer:
- Opportunity to work in a dynamic team.
- Professional development and growth opportunities.
- A motivating and performance-oriented work environment.
- A competitive salary and benefits package.
- Support for ongoing education and training.