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 organizations 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 EU MDR 2017/745 MDSAP Support CAPA, non conformance, and deviation investigations, including root cause analysis Contribute to audit readiness and assist with responses to FDA, Notified Body, and customer audits Track and report quality metrics and remediation progress Collaborate cross-functionally with QA, Manufacturing, Engineering, and...