QMS Integration Specialist
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Job Summary
Supporting the integration of an acquired company's Quality Management System (QMS) into the existing medical-device quality system, the 18-month remote QMS Integration Specialist will conduct gap assessments, perform process mapping, and create relevant documentation.
Key responsibilities
- Conduct QMS gap assessments against FDA regulations and ISO standards
- Perform process mapping and identify gaps between quality systems
- Create, update, and revise SOPs, procedures, and work instructions
Required qualifications
- Strong experience with Quality Management Systems (QMS)
- Experience with medical device quality systems, preferably Class III devices
- Proficiency in technical writing, including SOP creation and documentation
- Experience in QMS gap analysis and process mapping
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