Quality Engineer

Responsibilities

• Support and maintain applicable Quality System requirements for Commercial Logistics and Operations Service Centers (OSCs) in the U.S.
• Provide technical support for instrument inspection activities carried out in Memphis Shared Services, OSCs, Distributorships, and Customer accounts.
• Support Quality Managers and Directors, and maintain working relationships with Internal Commercial Logistics and Inventory teams, OSC employees, Distributorships, 3rd‑party Contractors, and the Sales Organization.
• Design and implement Electronic Field Inspection Procedure (EFIP) Architecture, Advanced Troubleshooting, and eFIP data analytics.
• Support New Product Support initiatives including Field Inspection/Calibration/PFMEA, and create & maintain Field Quality Processes and Procedures.
• Assist with GDC and Field Quality related CAPAs, Quality Holds, and Non‑Conformances (NC).
• Support Quality Managers in various Field Office, Commercial Operations, and Distribution Projects.
• Perform verification and validation of requirements for finished and purchased products, raw materials, or related processes.
• Execute visual, basic dimensional, and associated documentation inspections per specified procedures within GMP framework.
• Apply technical measurement equipment, advanced PC usage, and associated software.
• Apply knowledge of statistics, advanced mathematics, and drawing print reading/interpretation; perform root cause analysis and suggest alternate methods for resolution.
• Train others in correct use and care of instruments and inspection methods used in the medical device industry.

• Bachelor of Science Degree in Mechanical, Bio‑Medical, Manufacturing, or Industrial Engineering required.
• ASQ CQE preferred.
• Two (2) years intermediate engineering level experience in quality control or manufacturing required.
• Knowledge and understanding of FDA QSR, ISO 13485 and 14971 required.
• Working knowledge of at least two (2) RCA techniques preferred.
• Proficiency in verifying and validating requirements, and performing visual, dimensional, and documentation inspections within GMP standards.
• Strong written and verbal communication skills.
• Physical demands: approximately one‑third of the time walking or standing; up to 60% at a computer; ability to use hand instruments and exhibit excellent vision.

• 401(k) Matching Program
• 401(k) Plus Program
• Discounted Stock Options
• Tuition Reimbursement
• Flexible Personal/Vacation Time Off
• Paid Holidays, Flex Holidays, Paid Community Service Day
• Medical, Dental, Vision, Health Savings Account with employer contribution of $500+ annually
• Employee Assistance Program
• Parental Leave, Fertility and Adoption Assistance Program
• Hybrid Work Model (for most professional roles)
• Hands‑On, Team‑Customized, Mentorship training
• Discounts on fitness clubs, travel and more

Smith+Nevhprovides 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.