A global Medical Device company is seeking a Quality Systems Auditor II to join their manufacturing site in Naples, FL. This role involves conducting internal quality system audits to ensure compliance with industry standards and regulations related to the development, manufacturing, and distribution of medical devices. This company is focused on innovating medical devices within the orthopedic sector.
This opportunity is for candidates who can commute on-site or relocate to Naples, FL.
Key Responsibilities:
- Plan and execute internal quality audits.
- Apply relevant regulations to organizational processes.
- Identify nonconformances and monitor the effectiveness of corrective actions.
- Prepare and distribute detailed audit reports.
- Travel as necessary.
- Track and analyze quality audit data.
- Evaluate processes and collaborate to identify opportunities for improvement and efficiency.
- Work with process owners to ensure compliance with Quality Management System requirements.
Education and Experience:
- Bachelor's degree required.
- Minimum of 2 years of experience in quality auditing.
- Certification as a Quality Auditor or Qualified Lead Auditor is preferred.
Knowledge:
- Competency in quality auditing (e.g., ISO 19011) is preferred.
- Familiarity with international regulations and standards for medical devices, including ISO 13485, is preferred.
- Understanding of statistical processes and trending is preferred.
