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Lead Auditor, Medical Devices (Home-based in USA)

Lead Auditor, Medical Devices (Home-based in USA)

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Lead Auditor, Medical Devices (Home-based in USA)

About the job

Our client are seeking a Lead Auditor to support their Medical Device division.

Your tasks will include:

  • Perform regulatory audits of clients per European Medical Device Directives (IVDD, MDD, AIMD) and new Regulations (IVDR, MDR), Medical Device Single Audit Program (MDSAP), and International quality system standards (e.g. ISO 13485, ISO 14971) as well as internal Notified Body criteria.
  • All related tasks, such as scheduling, planning, reviewing corrective actions, preparing reports and audit documentation for submission to the certification committee of the Notified Body.

File reviews:

  • Perform evaluations of regulatory submissions including: product-specific Technical Documentation assessments (EU Directives), Design Dossier reviews (EU Directives)

Project Management:

  • Provide project management for NAFTA-based customers.
  • Facilitate the issuance of quotes
  • Coordinate with other personnel (Account Executives, Project Coordinators, Service Line Managers) to handle a variety of audit projects and other client requests
  • Identify and coordinate audit teams
  • Communicate in a courteous and effective manner with internal and external customers in all circumstances including answering questions, relaying messages, and providing information with regard to international standard, regulatory and technical requirements for compliance purposes.

Requirements:

  • BA or BS Degree in a science related field (biotechnology, molecular biology, biochemistry, microbiology, mechanical engineering, electrical engineering, bioengineering, etc.). A MS or PhD is preferred.
  • Minimum of 5 years' experience in an industrial medical device environment in the area of Product Design / Product Development / Manufacturing of IVD, Non-Active Medical Products, or Active Medical Products.
  • Minimum 2 years' experience with quality management-related activities (e.g. design control, process/product/method validation, design transfer, risk management, manufacturing controls, QC testing). Auditing training/experience is a plus;
  • Minimum 2 years' experience with quality management-related activities (e.g. design control, process/product/method validation, design transfer, risk management, manufacturing controls, QC testing). Auditing training/experience is a plus; Openness to relocation to Central and Eastern US is a plus;
  • Regular domestic travel (>50%) and international travel is required.