Quality System Specialist Ii (fort Worth, Tx)

Smith+Nephew

Fort Worth, TX, US
Not specified; not specified; benefits: 401k match...
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 compliance, maintenance, and oversight of the Quality Management Systems at the Fort Worth Facility

Job Summary

  • The Quality Management Systems Specialist II is responsible for compliance, maintenance, and oversight of the Quality Management Systems at the Fort Worth Facility.
  • The role involves leading governance forums, generating KPIs, and driving continuous improvement using Lean or Six Sigma methodologies to reduce quality events.
  • 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 compliance, maintenance, and oversight of the Quality Management Systems at the Fort Worth Facility.

Salary

Not specified; Not specified; Benefits: 401k Matching, Tuition Reimbursement, Medical/Dental/Vision, Hybrid Work Model

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 certification
  • Auditor training or certification preferred
  • Familiarity with 21 CFR Part 11, 58, 210, 211, 600, and 820

Key Requirements

  • Bachelor's degree required
  • 2-5 years medical device/pharma experience
  • Proficiency in Microsoft Office Project/Excel/Word/PowerPoint

Work Rights

Not specified

Tailored Resume

Cover Letter