Medical Device Audit Lead
4 weeks ago
About the Role:
The Medical Device Lead Auditor will be responsible for performing medical device audits in accordance with applicable regulations and standards. This includes auditing clients per Medical Device Regulations (IVDR, MDR), Medical Device Single Audit Program (MDSAP), international quality system standards (e.g. ISO 13485, ISO 14971), and internal Notified Body and TÜV SÝ America criteria.
Key Responsibilities:
- Auditing: Perform regulatory audits of clients, reviewing and preparing reports and audit documentation for submission to the certification committee of the Notified Body.
- File Reviews: Evaluate regulatory submissions, including product-specific Technical Documentation assessments (EU Regulations) and Design Dossier reviews (EU Regulations).
- Project Management: Provide project management for NAFTA-based customers, facilitating the issuance of quotes and coordinating with other TÜV SÝ America personnel to handle audit projects and client requests.
- Communication: Communicate effectively with internal and external customers, including answering questions, relaying messages, and providing information on international standards and regulatory requirements.
Requirements:
A Master's degree or foreign equivalent in Bioengineering, Regulatory Science, Project Management, or a related field, plus 3 years of experience in an industrial medical device environment in Product Design, Product Development, or Manufacturing of IVD, Non-Active Medical Products, or Active Medical Products, including at least 1 year of experience with quality management-related activities.
How to Apply:
Apply online at https://www.tuvsud.com/en-us/careers or send resume to: Dennis Moore, Manager, Talent Acquisition, TÜV SÝ America Inc., 401 Edgewater Place, Ste 500, Wakefield, MA 01880. An EOE.
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