Description
The Senior Quality Engineer (SQE) will work as part of a core team supporting Production and new product introduction activities. They will be responsible for establishing, implementing and maintaining systems and /or services to measure and improve product quality while ensuring full compliance to FDA QSR (21 CFR 820), and applicable ISO 13485 requirements. They will liaise with customers with regard to specification alignment, acceptance criteria, and test methods. The SQE will also assist in issues related to Metrology, Inspection, Testing, and Supplier Qualifications.ESSENTIAL DUTIES AND RESPONSIBILITIES:
* Participates as a key member of new product development, to help ensure that the new product quality plans, validation plans, specifications, are properly established.
* Executes on process improvements to improve product quality and manufacturability.
* Designs and Develops forms and instructions for recording, evaluating, and reporting quality data
* Interfaces with suppliers to improve or resolve quality issues
* Perform Gauge R&R Studies, IQ, OQ, and PQ Concepts, CAPA compliance.
* Perform Metrology and General Statistics to aid the improvement of processes.
* As part of the Quality team will demonstrate the importance of compliance and quality in all aspects of what they do.
REQUIREMENTS:
* Bachelor's Degree with a scientific emphasis required.
* Minimum of 5 years' experience in a regulated medical device environment.
* ASQ certified Quality Engineer recommended
* Six Sigma Green/Black belt an advantage.
* Excellent verbal and written communication skills
* Medical Device Experience preferred
To find out more about Real please visit www.realstaffing.com