Medical Device Audit Lead

4 weeks ago


Wakefield, Wakefield, United Kingdom TÜV SÜD Full time

Medical Device Audit Lead

As a Medical Device Audit Lead at TÜV SÜD, you will be responsible for performing medical device audits in accordance with applicable regulations and standards. Your duties will include auditing clients per Medical Device Regulations (IVDR, MDR), Medical Device Single Audit Program (MDSAP), and international quality system standards (e.g. ISO 13485, ISO 14971). You will also perform related tasks such as scheduling, planning, reviewing corrective actions, and preparing reports and audit documentation for submission to the certification committee of the Notified Body.

Key Responsibilities:

  • Auditing: Perform regulatory audits of 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 SÜD America criteria.
  • File Reviews: Perform evaluations of regulatory submissions including product-specific Technical Documentation assessments (EU Regulations), Design Dossier reviews (EU Regulations).
  • Project Management: Provide project management for NAFTA-based customers; Facilitate the issuance of quotes; Coordinate with other TÜV SÜD America personnel (Account Executives, Project Coordinators, Service Line Managers) to handle a variety of audit projects and other client requests.

Requirements:

  • Master's degree or foreign equivalent in Bioengineering, Regulatory Science, Project Management, or a related field.
  • 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.
  • At least 1 year of experience with quality management-related activities, such as design control, process/product/method validation, design transfer, risk management, manufacturing controls, or QC testing.

Apply online at https://www.tuvsud.com/en-us/careers or send resume to: Dennis Moore, Manager, Talent Acquisition, TÜV SÜD America Inc.



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