Quality Engineer II #JN -062021-64845
*Hiring manager is willing to consider recent college graduates with the required degree. *Customer willing to train successful candidate. GREAT PAY, GREAT 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.
- 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.
- 70% - Support receiving inspection and in process inspection personnel. Enable optimization of any inspection efficiencies. Update inspection procedures and drawing.
- 30% - Initiate, identify root cause, evaluate, and document corrective and preventive action following the Quality Management System requirements for CAPA. 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. Document, evaluate, and record process validation protocols, testing, and reports for process optimization related to current production and future production of new designs. 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.
- 0% - Travel: No travel required.
- Bachelor's degree in Engineering, Physics, Chemistry or Biology Required.
- Quality Engineer, 3-5 years in Medical Device / Biologics / IVD manufacturing experience preferred.
- Considerable hands-on experience in Medical Device manufacturing with strong working knowledge of FDA QSR and ISO 13485 preferred.