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.
Support receiving inspection and in process inspection personnel. Enable optimization of any inspection efficiencies. Document, evaluate, and disposition any nonconformances identified during inspection.
Document, evaluate, and record process validation protocols, testing, and reports for process optimization related to current production and future production of new designs.
Initiate, identify root cause, evaluate, and document corrective and preventive action following the Quality Management System requirements for CAPA.
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.
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.
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%
Travel Some travel required
Education Bachelor's degree in Engineering.
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
Nesco Resource is an equal employment opportunity employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, or veteran status, or any other legally protected characteristics with respect to employment opportunities.
Corrective And Preventive Action (Capa)
Quality Management Systems