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
- FDA (21 CFR Part 820)