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Senior Specialist, Quality Systems

4 months ago

Fort Myers Beach, United States EPM Scientific Full time

Senior Specialist, Quality Systems and Regulatory Compliance


Location: Fort Myers, 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 of Quality Systems and Regulatory Compliance for our manufacturing site. The Senior Specialist of Quality Systems and Regulatory Compliance will be supporting the Global CAPA Department to ensure the Quality Management System is in compliance with all regulatory requirements.


The Senior Specialist, Quality Systems and Regulatory Compliance 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, Quality Systems and Regulatory Compliance 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