Quality Engineer 2

Smith+Nephew•Memphis, TN

4d•Hybrid

About The Position

Life Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living. This position is responsible for supporting and maintaining applicable Quality System requirements for Commercial Logistics and Operations Service Centers (OSCs) in the U.S. as well as providing technical support pertaining to instrument inspection activities carried out in Memphis Shared Services (Building M), OSCs, Distributorships, and Customer accounts. The role will directly support Quality Managers and Directors. The individual in this role will need to maintain working relationships inclusive of but not limited to the internal Commercial Logistics and Inventory teams, employees in the Operation Service Centers throughout the U.S., Distributorships, 3rd party Contractors, and the Sales Organization. What will you be doing? Primary responsibilities include Electronic Field Inspection Procedure (EFIP) Architecture and Advanced Trouble Shooting, eFIP data analytics, New Product Support - Field Inspection/Calibration/PFMEA, Creation & Maintenance of Field Quality Process and Procedures, supporting GDC and Field Quality related CAPAs, Quality Holds, and Non-Conformances (NC). This job will also directly support Quality Managers for support of various Field Office, Commercial Operations, and Distribution Projects. May be cross trained and assigned to other Quality Control areas, if job requirements dictate. Must be proficient in the verification and validation of requirements for finished and purchased products, raw materials, or related processes. Must be able to establish and support visual, basic dimensional, and associated documentation of inspections per specified procedures or instructions within the framework of the Good Manufacturing Practices (GMPs) standards. Position will require the use of technical measurement equipment and knowledge of advanced use of PC and computer systems, and associated software. Knowledge of statistics, advanced mathematics, and Drawing Print Reading/Interpretation is required. Able to perform root cause analysis (RCA), determine actions to correct and prevent recurrence of issues, and able to suggest alternate methods for resolution. Working knowledge of at least two (2) RCA techniques is preferred. This job will require training others in the correct use and care of instruments and inspection methods used in the medical device industry.

Requirements

Bachelor of Science Degree in Mechanical, Bio-Medical, Manufacturing, or Industrial Engineering required.
Two (2) years intermediate engineering level experience in quality control or manufacturing is required.
Knowledge and understanding of FDA QSR, ISO 13485 and 14971 is required.
Must possess good written and verbal skills.
Position will require the use of technical measurement equipment and knowledge of advanced use of PC and computer systems, and associated software.
Knowledge of statistics, advanced mathematics, and Drawing Print Reading/Interpretation is required.

Nice To Haves

ASQ CQE preferred.
ASQC CQE preferred
Working knowledge of at least two (2) RCA techniques is preferred.

Responsibilities

Electronic Field Inspection Procedure (EFIP) Architecture and Advanced Trouble Shooting
eFIP data analytics
New Product Support - Field Inspection/Calibration/PFMEA
Creation & Maintenance of Field Quality Process and Procedures
supporting GDC and Field Quality related CAPAs, Quality Holds, and Non-Conformances (NC)
support Quality Managers for support of various Field Office, Commercial Operations, and Distribution Projects
verification and validation of requirements for finished and purchased products, raw materials, or related processes
establish and support visual, basic dimensional, and associated documentation of inspections per specified procedures or instructions within the framework of the Good Manufacturing Practices (GMPs) standards
perform root cause analysis (RCA), determine actions to correct and prevent recurrence of issues, and able to suggest alternate methods for resolution
training others in the correct use and care of instruments and inspection methods used in the medical device industry