Description
SUMMARYResponsible for the maintenance of quality systems and facilitate continuous quality improvements. This position is responsible for the maintenance and monitoring of a variety of cGMP documentation including complaint files, complaint processing system, investigations and closure, corrective action and preventive actions (CAPA), product investigations and maintenance of other related quality system records as required.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Provide guidance to the team regarding the complaints to ensure appropriate action and closure.
- Conduct product and complaint investigations with follow-up as required for associated CAPAs.
- Analyze and report department metrics using Oracle and Microsoft-based applications.
- Assist with the maintenance of quality systems and facilitate continuous quality improvements.
- Conduct reviews and provide monthly reports for department metrics
- Support internal, external, and third-party audits.
- Support technical needs of the department.
- Assume and perform other duties as assigned.
- Train employees in SOP's and ensure training effectiveness in application of job skills
Minimum Bachelor's degree (B.A.) from four-year College or university; Minimum two years related experience in Quality Assurance and/or training; or equivalent combination of education and experience. Experience supervising others is preferred. Minimum 1 year Nursing or Medical Background is highly desired.
KEYWORDS: Quality Assurance, QA, Compliance, complaint handling, investigations, medical device, san diego, carlsbad
To find out more about Real please visit www.realstaffing.com