Medical Device Quality Assurance Expert
vor 3 Wochen
As a key member of the Novartis QA Medical Device team, you will play a crucial role in supporting the commercialization of new medical devices worldwide.
Key Responsibilities:- Oversight of Production and Testing Activities: Ensure compliance with current Good Manufacturing Practices (cGMP), data integrity, and electronic compliance.
- Support Exception Investigations: Collaborate with the team to investigate and resolve exceptions in a timely and efficient manner.
- Review and Approval of Records: Review and approve production, quality control, and assurance and testing records to ensure accuracy and compliance.
- MBR Review: Conduct regular reviews of Master Batch Records to ensure compliance with regulatory requirements.
- OpEx Improvement Projects: Support operational excellence improvement projects to enhance efficiency and effectiveness.
- Reporting of Technical Complaints: Report technical complaints, adverse events, and special case scenarios related to Novartis products within 24 hours of receipt.
- Third-Party Management: Manage third-party suppliers of device components and primary packaging materials.
- Review and Approval of Documents: Review and approve Design History Files (DHF) and Device Master Records (DMR) documents for commercial medical devices and combination products.
- Education: University degree in Engineering, Pharmacy, Biochemistry, Biotechnology, Chemistry, Microbiology, or equivalent.
- Experience: At least 3 years of experience in Manufacturing, Supply Chain, Quality Control, or Quality Assurance in the medical device industry.
- Skills: Experience in operations management, execution, negotiations, and global collaboration.
- Language: Fluent knowledge of English (written and spoken), with German being an advantage.
- Flexibility: Ability to work in a fast-paced, quickly changing work environment.
- Global Matrix Environment: Experience operating in a global matrix environment.
Novartis is a leading global healthcare company that is committed to reimaging medicine to improve and extend people's lives. Our purpose is to become the most valued and trusted medicines company in the world.
We offer a competitive base salary, an attractive incentive program, a modern company pension scheme, childcare facilities, learning and development opportunities, and worldwide career possibilities within the Novartis group.
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