Description
SUMMARY:This Quality Engineer will be supporting the Quality System Softward documentation, testing, validation, and QMS tool maintenance activities.
DUTIES AND RESPONSIBILITIES:
* Participate in the 12-month retrospective reviews for CAPA, Complaints, CORs, and Design History Files.
* Review CAPAs for compliance to 21CFR Part 820
* Review Complaints for compliance to 21CFR Part 820
* Review design and manufacturing change order requests to ensure compliance to DJO processes
* Review design history files and technical files to ensure compliance to DJO processes; generate electronic files
QUALIFICATIONS:
* A minimum of 5 years of experience in the medical device domain in either Quality Assurance or Quality Control.
* Experience with managing nonconforming material and quality control activities
* Experience with MS Office required
* Experience Agile PLM is required
* Experience with Oracle desirable
This is an extremely urgent role. Please get in touch ASAP to discuss.