Medical Device Quality Assurance (CAPA/Complaints)

Indianapolis, IN

Job ID: 130375 Industry: Med

Medical Device QA Specialist (CAPA/Complaints)

Environment:

Our client is a manufacturer of Medical Devices and high-precision metal and plastic components. Looking for QA support to help with backlogged CAPA’ s and Complaints as well as help with sustaining activities.

Job Duties/Responsibilities:

This person will be supporting the Quality department and will be handling CAPA and Complaint backlogs as well as some sustaining activities. The activities will most likely will be split close to 50/50. The client primarily uses a paper based system so familiarity and comfort with paper based systems is a must. This is not a complaint handling role, this consultant will be responsible for the full lifecycle - reviewing complaints, initiating CAPA’ s when necessary, investigating manufacturing deviations and producing all the necessary reporting to close the CAPA’ s out. The client is interested in hearing about continuous improvement activities as well so any experience with system development and teaching best practices would be very welcome.

Required:

Medical Device 5+ years

Quality Assurance

CAPA/ Complaint Investigations

Experience with Paper Based Systems

Desired:

System Development

Job Type: Contract  

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