Description
Job DetailsDUTIES 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 processes
* Review design history files and technical files to ensure compliance to 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 desirable
* Experience with Oracle desirable
Please submit reume as soon as possible to be considered for submission