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Medical Device Auditor

  • Job type: Permanent
  • Location: Houston, Texas
  • Salary: Full Benefits
  • Job reference: 447943/001_1560291759
  • Sector: Pharmacology, EPM Scientific
  • Date posted: 11/06/2019

Medical Device Auditor (100% Remote)

USA (Home-Based)

A well-established company in a rapidly growing industry is seeking to increase its head count of Medical Device Auditors! These positions as home-based (100% remote) and require extensive travel to conduct audits across the country. If you are looking for your next medical device opportunity that affords you the flexibility to work remotely than don't hesitate to apply!

The Medical Device Auditor will have the following responsibilities:

  • 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).

  • All related tasks, such as scheduling, planning, reviewing corrective actions, preparing reports and audit documentation for submission.

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

  • Provide project management for customers.

  • Coordinating with other personnel (Account Executives, Project Coordinators, Service Line Managers) to handle a variety of audit projects and other client requests

  • Identifying and coordinating 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.

The ideal candidate will have:

  • 4 + years QA experience in the medical device industry

  • Auditing Experience in medical device industry

Bachelor's degree in a science or engineering discipline

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