SaMD QA/ RA Associate

Full Time


Who we are looking for:

A seasoned Quality Assurance/ Regulatory Assurance Associate to help drive and maintain our medical device Quality Management System.

Must be able to:

  • Support Director of SaMD Compliance and Senior SaMD Compliance Managers in fulfilling business and Company quality objectives
  • Develop a sophisticated understanding of FDA guidance relevant to Company projects
  • Author and revise Standard Operating Procedures (SOPs), Work Instructions (WIs) and QMS templates in accordance with ISO 9001, ISO 13485, ISO 14971 and CFR 820 Part 30. Knowledge of these guidance documents/standards is required.
  • Assist in authoring and revising medical device project specific documentation
  • Create employee training plans and communicate training requirements to team members
  • Ensure all team training is completed in a timely manner
  • Maintain employee training records
  • Support Development Tool Validation from a quality perspective
  • Support internal audit program, ISO 13485 internal audit certification a place.
  • Support the management of CAPA program

Who we are:

Idea Evolver is an independent Medical Software and Health Marketing company. Notable clients include AstraZeneca, Bluebird Bio, Horizon Pharmaceuticals, and Danone North America.

Compensation package includes:

  • Very competitive salary
  • Excellent health and dental
  • Awesome equipment
  • 401k
  • 20 days off plus holidays and a winter break
  • Work From Anywhere position

We look forward to hearing from you!

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