Senior Specialist - CAPA
Location: Tampa, FL
Working Situation: Onsite
Level: Mid-Senior Level
Our client is a global medical device company who is the industry leader of new product development. Our innovative company is actively searching for a new Senior Specialist - CAPA for our manufacturing site. The Senior Specialist - CAPA will be supporting the Global CAPA Department to ensure the Quality Management System is in compliance with all regulatory requirements.
The Senior Specialist - CAPA will be responsible for:
- Organize and oversee projects to ensure QMS compliance.
- Manage records such as CAPA, NCR, and Deviation Records for compliance.
- Review and generate reports on Quality Systems Records.
- Provide guidance on QMS software and procedures.
- Assist in writing and revising QMS documents.
- Support training activities for new and current employees.
- Aid in the development and review of QMS documents for compliance.
- Perform data trending to monitor compliance and management goals.
- Prepare presentations for CAPA Review Board and Management Reviews.
- Support internal and external audits as Quality Systems SME.
The Senior Specialist - CAPA will have the following qualifications:
- Bachelor's degree in Science, Engineering, or related field
- 7+ years of experience with NCs, CAPA, and Deviations
- Knowledge of ISO 13485, 21 CFR Part 820
If you are interested in this Senior Specialist, Quality Systems and Regulatory Compliance opportunity, apply now!
