Quality Auditor II
An Industry-leading medical device company is seeking a Quality Systems Auditing expert for their site in Naples, Florida. They will conduct internal quality system audits to evaluate and ensure conformance to industry standards and regulations related to the development, manufacture, and distribution of medical devices.
Essential Duties and Responsibilities:
- Prepare for and perform internal quality audits. Write and distribute audit reports
- Apply relevant regulations to organizational processes
- Issue nonconformances and follow up on corrective actions
- Track and trend quality audit data. Analyze processes and collaborate to identify opportunities for improvements and efficiencies
- Work with process owners to ensure procedures and policies comply with Quality Management System requirements
Education and Experience:
- Required: Bachelor's degree
- Required: 2+ years of quality auditing experience
- Certified Quality Auditor or Qualified Lead Auditor preferred
- ISO 19011 and ISO 13485 experience
Knowledge:
- Competency in quality auditing (e.g., ISO 19011) preferred
- Familiarity with international regulations and standards for medical devices, including ISO 13485, preferred
- Knowledge of statistical processes and trending preferred
Please apply if you are interested in joining a talented team dedicated to improving patient outcomes!
