At Smith+Nephew, we design and manufacture technology that takes the limits off living, and this role drives compliance with regulatory requirements like GMP, GxP, and FDA
Job Summary
At Smith+Nephew, we design and manufacture technology that takes the limits off living, and this role drives compliance with regulatory requirements like GMP, GxP, and FDA.
The Quality Systems Specialist 3 will lead and maintain the Quality Management System, manage key quality system processes, and generate quality metrics to identify trends.
The company offers a comprehensive benefits package including 401k matching, tuition reimbursement, and a hybrid work model for most professional roles.
Matching Summary
At Smith+Nephew, we design and manufacture technology that takes the limits off living, and this role drives compliance with regulatory requirements like GMP, GxP, and FDA.
Skills & Requirements
Must-have
Quality Management System leadership
CAPA, Non-Conformance, change management
internal and external audit leadership
manufacturing floor quality expertise
cGMP, FDA regulations and guidance
Nice-to-have
problem-solving methodologies
continuous improvement culture
collaboration with site personnel
coaching and mentoring colleagues
Key Requirements
Bachelor’s degree in science, engineering, life sciences or related field
Minimum of 5 years of experience in a Quality Systems role
Experience with GMP, FDA regulations, internal audits and quality investigations
Lean or Six Sigma Yellow or Green Belt preferred
Certified Quality Auditor (CQA) or Lead Auditor training (ISO 13485) highly desired