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QMS Consultant
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.
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
EU MDR 2017/745
MDSAP
Requisitos: Requirements: Bachelor’s degree in Engineering, Life Sciences, Quality, or related technical field 5+ years of QA experience in a regulated industry (medical device preferred) Strong knowledge of quality regulations and standards (FDA, ISO 13485, MDR, MDSAP) Experience with CAPA, audits, document control, and quality systems Requiere Mucha Experiencia Requires Expert
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