This position is responsible for providing subject matter expertise in the CAPA process. The individual will serve as a point of contact and assist with investigating, planning, and implementing improvements to products and processes.
1. In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
2. Serve as a resource to CAPA investigations for conducting root cause analysis and developing and implementing corrective action plans.
3. Maintain and manage positive working relationships and ensure appropriate representatives from affected departments are involved while assisting in all stages of CAPA management and resolution.
4. Ensure that every activity performed in the CAPA process is accurately documented and that all timeframes for reporting or resolution are met.
5. Provide assistance in generation of management review metrics for CAPA as required.
6. Develop and maintain knowledge of CAPA, including understanding of current technologies and trends, through actions such as professional memberships, attendance at conferences and/or seminars, subscription to trade magazines, etc.
7. Serve as a point of contact in processing, monitoring, reporting, and resolving problems and process improvements.
8. Facilitate the CAPA Review Board.
9. Perform other duties as assigned. |
Requires a four-year college degree in an engineering, scientific, or technical discipline and a minimum of six years of experience in CAPA processes. Intermediate computer software skills, i.e. Microsoft Office. Master’s degree preferred. Experience with Six Sigma Process Excellence tools, training, and/or certification preferred. |
