Quality System Specialist Ii (fort Worth, Tx)

Smith & Nephew

Fort Worth, Texas, US
Hybrid
Quality management system oversight
Capa, non-conformance, change management
Kpi generation and trend analysis
The Quality Management Systems Specialist II is responsible for compliance, maintenance, and oversight of the Quality Management Systems managed at the Fort Worth Facility to ensure the systems function in compliance with corporate and regulatory agency requirements

Job Summary

  • The Quality Management Systems Specialist II is responsible for compliance, maintenance, and oversight of the Quality Management Systems managed at the Fort Worth Facility to ensure the systems function in compliance with corporate and regulatory agency requirements.
  • Leading and coordinating key governance forums including CAPA Review Board, QMR, QDR and change control.
  • Smith+Nephew provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability.

Matching Summary

The Quality Management Systems Specialist II is responsible for compliance, maintenance, and oversight of the Quality Management Systems managed at the Fort Worth Facility to ensure the systems function in compliance with corporate and regulatory agency requirements.

Skills & Requirements

Must-have

  • Quality Management System oversight
  • CAPA, non-conformance, change management
  • KPI generation and trend analysis
  • Continuous improvement methodologies
  • Audit preparation and support
  • Guidance and coaching to teams

Nice-to-have

  • Lean or Six Sigma methodologies
  • Collaborative problem-solving
  • Articulate quality issues effectively

Key Requirements

  • Bachelor’s degree in science, engineering, life sciences or related field
  • 2-5 years' experience in quality systems role
  • Medical device, pharmaceutical or biotech manufacturing experience
  • Lean or Six Sigma Yellow or Green Belt preferred
  • Auditor training or certification preferred
  • Familiarity with 21.CFR Part 11, 58, 210, 211, 600, and 820 preferred

Work Rights

Not specified

Tailored Resume

Cover Letter