Quality System Specialist Ii (fort Worth, Tx)

Smith+Nephew

Fort Worth, TX, US
Hybrid
Bachelor's degree in science or engineering
2-5 years quality systems experience
Deep understanding of cgmp and fda regulations
The Quality Management Systems Specialist II is responsible for ensuring the Fort Worth Facility's systems comply with corporate and regulatory agency requirements

Job Summary

  • The Quality Management Systems Specialist II is responsible for ensuring the Fort Worth Facility's systems comply with corporate and regulatory agency requirements.
  • This role involves leading key governance forums such as the CAPA Review Board and generating KPIs to provide visibility to site leadership.
  • Smith+Nephew offers a comprehensive benefits package including 401k matching, tuition reimbursement, and a hybrid work model for most professional roles.

Matching Summary

The Quality Management Systems Specialist II is responsible for ensuring the Fort Worth Facility's systems comply with corporate and regulatory agency requirements.

Skills & Requirements

Must-have

  • Bachelor's degree in science or engineering
  • 2-5 years quality systems experience
  • Deep understanding of cGMP and FDA regulations

Nice-to-have

  • Lean or Six Sigma Yellow or Green Belt
  • Auditor training or certification preferred
  • Familiarity with 21 CFR Part 11 and 820

Key Requirements

  • Bachelor's degree required
  • 2-5 years medical device/pharma experience
  • Proficiency in Microsoft Office Suite

Work Rights

Not specified

Tailored Resume

Cover Letter