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Quality Engineer III


Location: Cordova , Tennessee
Job Category:


Provide quality engineering floor support for production area to ensure production is able to expand capacity and volumes. Document, evaluate, and disposition any nonconformances associated with production.

30%
Support receiving inspection and in process inspection personnel. Enable optimization of any inspection efficiencies. Document, evaluate, and disposition any nonconformances identified during inspection.
20%
Document, evaluate, and record process validation protocols, testing, and reports for process optimization related to current production and future production of new designs.
10%
Initiate, identify root cause, evaluate, and document corrective and preventive action following the Quality Management System requirements for CAPA.
10%
Complete inspection and evaluation of finished products in pre-sterile quarantine, post-sterile quarantine, and finished goods kitting locations. Ensure full conformance to specification requirements.
10%
Assist in the transfer of production activities to a 2nd manufacturing location to enable increased production capacity. Ensure conformance to requirements for all manufacturing locations.
10%
Ensure that quality reporting (e.g. incoming and in-process quality trends; returns analysis, categorization and corrective action activity, etc.) is maintained and documented with the assigned team; 10%

REQUIREMENTS
Travel Some travel required

Education Bachelor's degree in Engineering.


Licenses/Certifications

Experience Quality Enginer, Minimum 3-5 years in Medical Device / Biologics / IVD manufacturing experience. Considerable hands-on experience in Medical Device manufacturing with strong working knowledge of FDA QSR and ISO 13485

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