Senior Quality Manager

BD

Plainfield, IN, USA
Iso 13485 and 21 cfr 820 compliance
Medical device quality management system
Warehouse and distribution experience
This role ensures the distribution center maintains a robust Quality Management System compliant with ISO 13485 and 21 CFR 820 regulations

Job Summary

  • This role ensures the distribution center maintains a robust Quality Management System compliant with ISO 13485 and 21 CFR 820 regulations.
  • The Senior Quality Manager is responsible for leading local site implementation of annual Quality Objectives and managing effective returns and re-boxing operations.
  • Candidates will apply metrics to drive process improvement, manage non-conforming inventory, and partner with supply chain teams to resolve critical issues.

Matching Summary

This role ensures the distribution center maintains a robust Quality Management System compliant with ISO 13485 and 21 CFR 820 regulations.

Skills & Requirements

Must-have

  • ISO 13485 and 21 CFR 820 compliance
  • Medical device Quality Management System
  • Warehouse and Distribution experience
  • ERP/WMS quality functionalities
  • Root cause analysis and corrective actions
  • Non-conforming product management

Nice-to-have

  • Analytical thinking and problem solving skills
  • Multi-functional working matrix collaboration
  • Influencing others across the organization
  • Proactive improvement culture promotion
  • Carrier claims resolution experience

Key Requirements

  • B.S. or B.A. in Engineering or Science
  • 8-10 years experience leading a quality function
  • QMS experience in medical device preferred

Work Rights

Not specified

Tailored Resume

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