Job Description

Description

The Quality Systems & Improvement Leader is responsible for ensuring the effectiveness, compliance, and continuous improvement of the site Quality Management System (QMS). This role provides leadership and oversight of quality system processes, including electronic Device History Records (eDHR), and drives initiatives to enhance quality, compliance, and operational efficiency.

Responsibilities:

  • Be the Guardian of Compliance: Ensure our site Quality Management System (QMS) stays ahead of the curve—maintaining full compliance with corporate standards, FDA regulations, ISO 13485, and industry best practices
  • Drive Performance Through Data: Monitor and analyze quality system performance using metrics, trend analysis, and internal audits.
  • Lead Digital Transformation: Oversee the implementation of our site's eDHR (electronic Device History Record) program
  • Innovate & Improve: Spearhead q...

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