Quality Engineering Manager
4 settimane fa
We are seeking a highly skilled Quality Engineering Manager to join our team at Orthofix. As a key member of our Quality Engineering team, you will be responsible for ensuring the efficacy and effectiveness of our products.
The successful candidate will have a strong background in quality assurance and regulatory compliance, with experience in managing teams and coordinating cross-functional projects. You will work closely with our Design & Development team to ensure that our products meet the highest standards of quality and regulatory requirements.
Key responsibilities will include:
- Coordinating the team to support internal departments during the product development process
- Managing risk management activities during product development, modification, and post-market surveillance
- Conducting design validation of new products in cooperation with R&D, Marketing, Medical Science, and Clinical Affairs
- Preparing and maintaining technical files for new products or modified products
- Supporting regulatory pre- and post-market activities related to technical aspects
The ideal candidate will have a strong understanding of European Medical Device Regulation EU 2017/745 and FDA guidelines, as well as experience with ISO 13485 and ISO 14971. You will also have excellent organizational skills, technical knowledge of medical devices, and the ability to work in a team and autonomously.
We offer a competitive salary package, including a base salary of €65,000 - €70,000 per year, as well as opportunities for professional growth and development. If you are a motivated and experienced quality professional looking for a new challenge, please submit your application to careers@orthofix.com.
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