Medical Device CAPA SME

Los Angeles, CA

Job ID: 131187 Industry: Medical Device

 

Medical Device CAPA Investigator

Environment:

Our client is a large medical device company that manufacturers class 2 & 3 products. They are currently in need of a CAPA investigator to lead remediation activities.

Responsibilities:

Our client is looking for a CAPA engineer to own CAPAs and drive them to completion. They will coordinate project planning on key corporate CAPA programs. Work with subject matter experts to develop plans and execute corrective action activities to resolve audit findings. They will lead teams in using problem solving tools and sound statistical analysis to find root causes of product and process issues to meet regulatory requirements and process improvement goals. They will need to have experience working with complaints and MDR since they will be completing their own CAPAs. They will effectively apply quality engineering knowledge and project management expertise to support initiatives and solve business problems, assist with data analysis and report preparation for all required data submissions. Track and report weekly during project reviews on status, successes, issues and slippage; budget and spending status if appropriate; next steps in the project effort to complete needed tasks along with other key project metrics. The ideal candidate will have experience in leadership. They are looking for a go-getter with a personable personality.

Required:
Medical Device-10 years experience 
CAPA
Complaints/MDR

Desired:
Ventilator devices
Manufacturing environment background 
Process Production Controls 

Job Type: Contract  

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