QMS Manager - North Charleston, SC
Only for registered members North Charleston, SC, United States
3 weeks ago
Job summary
Develops, establishes, and maintains the quality assurance programs, policies, processes, procedures, and controls ensuring that performance and quality of products conform to established standards and regulatory agency guidelines to ensure continued customer satisfaction.
Responsibilities
- Implement and maintain Charleston site Quality Management System in accordance with ISO 13485 and FDA regulations.
- Establish and maintain training system. Provide training, as appropriate.
- Coordinate, compilate and present Site Management Review. Responsible for trending/analysis of key performance indicator (KPI) data based on SOPs for recording, evaluation and reporting of Quality and reliability data.
- Plan, coordinate, and conduct scheduled internal audits to assess compliance with FDA, ISO, other applicable standard requirements, and internal requirements.
Job description
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