Quality System Specialist II (Fort Worth, TX)
Hybrid · Fort Worth, Texas, United States
Job Summary
Quality System Specialist II at Smith+Nephew in Fort Worth, TX oversees and maintains the Quality Management System to ensure alignment with internal procedures and regulatory standards. Responsibilities include owning CAPA, non-conformance and change control processes, leading governance forums (CAPA Review Board, QMR, QDR), generating KPIs and management reports, driving continuous improvement with Lean/Six Sigma, supporting internal/external audits, and coaching teams across manufacturing. Requires a Bachelor’s degree in a scientific or engineering field and 2-5 years in a quality systems role within medical device/pharma/biotech manufacturing, with preferred Lean/Six Sigma Yellow/Green Belt and auditor training. Knowledge of cGMP and FDA regulations (21 CFR 11, 58, 210, 211, 600, 820) and strong communication, analytical, and documentation skills are essential. Hybrid work model; up to 10% travel.
Required Qualifications
- Bachelor’s degree in science, engineering, life sciences or related field required
- 2-5 years' experience in a quality systems role within medical device, pharmaceutical or biotech manufacturing is required
- Lean or Six Sigma Yellow or Green Belt is preferred and auditor training or certification is preferred
- Knowledge of cGMP and FDA regulations; familiarity with 21 CFR 11, 58, 210, 211, 600, and 820 preferred
- Strong communication, problem-solving, and organizational skills
- Proficiency with Microsoft Word, Excel, PowerPoint; ability to generate KPIs and management reports
- Experience leading CAPA, non-conformance and change control processes
- Ability to coordinate audits and support readiness
- Experience providing guidance to manufacturing teams
- Ability to travel up to 10% (domestic and international)
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