Medical Device Quality Assurance Analyst

Remote • Posted 5 hours ago • Updated 5 hours ago
Contract W2
No Travel Required
Remote
$54/hr
Fitment

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Job Details

Skills

  • Analytical Skill
  • Communication
  • Medical Devices
  • Continuous Improvement
  • Documentation
  • ISO 13485
  • Management
  • QMS
  • Quality Assurance
  • Quality Management
  • Regulatory Compliance
  • Reporting
  • Science

Summary

Summary:

Seeking a Device Quality Assurance Specialist with experience in medical device quality systems to support the creation, management, and maintenance of Device Quality Management System (QMS) records while ensuring compliance with FDA and international regulatory standards.

Key Responsibilities:

  • Manage Device QMS records including complaints, deviations, CAPAs, change controls, and audits
  • Ensure compliance with FDA 21 CFR Part 820, ISO 13485:2016, and EU MDR
  • Support quality documentation, procedures, and continuous improvement initiatives
  • Track and report device quality metrics for management review

Requirements:

  • Bachelor’s degree in Science or related field
  • 3–5 years of experience in a medical device or regulated industry
  • Strong knowledge of 21 CFR Part 820 and ISO 13485
  • Strong analytical and communication skills
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
  • Dice Id: 91099677
  • Position Id: 8904499
  • Posted 5 hours ago
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