Job Description

Overview

As a Quality Engineering Manager, where you'll lead and/or coordinate the critical quality initiatives including product market release, investigations, trend analysis, product hold, field corrective actions, supplier audit, supplier quality management and continuous improvement.

Responsibilities

  • Product market release-responsible for medical device market release. Review the DHR from medical device supplier and approve or reject the medical device market release for each lot.
  • Participate supplier audits and regulatory/compliance agency audits. - coordinates regulatory inspections (NMPA audit to supplier), drive the supplier to respond to audit findings till closure; carries out supplier on-site audit, audit findings tracking, drive the corrections by supplier till closure.
  • Supplier quality management – work with cross-functional team on medical device supplier evaluation, supplier changes, NC and CAPA appr...

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