Quality Engineer II # JN -072021-67185
Posted on: July 16, 2021
Industry: QA Testers
Job Number: JN -072021-67185
- 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
- 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.
- Considerable hands-on experience in Medical Device manufacturing with strong working knowledge of FDA QSR and ISO 13485
Apply Online Apply Later