Quality Engineer II # JN -072021-67185

Description:

Position Functions

• 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

REQUIREMENTS

• 6 months minimum length, possible temp to full time opportunity !!! 
• BA/BS in Engineering and/or Life Science 
• NEW GRADS LOOKING FOR ENTRY LEVEL, LOTS OF TRAINING AND A CAREER WITH A FUTURE will be considered

Education Bachelor's degree in Engineering.

Experience: 

• Considerable hands-on experience in Medical Device manufacturing with strong working knowledge of FDA QSR and ISO 13485