CAPA SME

Colorado Springs, CO

Job ID: 131873 Industry: Medical Device

CAPA SME

Environment: 

Our client is a large medical device manufacturer that develops a number of Class II & III cardiac Medical Devices. They are currently in need of a CAPA SME to assist with  assessing and improving their  CAPA systems.

Responsibilities: 

This consultant will assist the client by assessing and improving   their  CAPA systems. They will also be required to work closely and contribute to a great deal of their current CAPAs in an efficient and timely manner. This consultant will be required to open current CAPAs, find risks, and develop solutions that will ultimately solve the issues related to those risks. They will also provide some CAPA coaching to CAPA coordinators on the team. The consultant for this role should consider themself a CAPA subject matter expert capable of efficiently identifying risks within CAPAs and guiding the client in a direction that make sense for remediation. 

Ideally this person will have worked for a Medical Device company to help CAPA process improvements, as well as the execution of back logged CAPAs. They should be an extremely effective communicator and comfortable working with all individuals of all levels and reporting progress back to management, etc.

Required:
  • CAPA: 5-8+  years
  • Medical Device: 5-8+ years
  • Quality Engineering
  • Extremely versatile in communicating with all levels of stakeholders/CAPA process owners, effective communicator

Plus:
  • Cardiovascular  Medical Device
  • Plastics

Job Type: Contract

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