QMS Consultant

QRC Group, LLC · Cidra, Cidra, Puerto Rico

Location
Cidra
Job Type
Full-time
Posted
June 17, 2026

Job Description


We are seeking a Quality Management System (QMS) Consultant to support a QMS Remediation Plan for critical quality system improvement initiatives within a regulated medical device environment. This role is key to identifying compliance gaps, driving remediation activities, and strengthening the organization’s QMS to meet global regulatory standards.

Key Responsibilities

  • Lead and support quality system remediation projects, including gap assessments and corrective action plans
  • Review, update, and enhance QMS documentation (procedures, work instructions, templates)
  • Ensure compliance with regulatory standards such as:
    • FDA (21 CFR Part 820)
    • ISO 13485:2016

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