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Medical Device Audit Lead

1 month 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 clients per Medical Device Regulations (IVDR, MDR)
  • Performing Medical Device Single Audit Program (MDSAP)
  • Conducting audits of international quality system standards (e.g. ISO 13485, ISO 14971)
  • Reviewing corrective actions and preparing reports
  • Preparing audit documentation for submission to the certification committee of the Notified Body

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.