What are the responsibilities and job description for the Quality Systems Senior Auditor position at EPM Scientific?
Senior Quality Systems Auditor Role
We are seeking a seasoned professional to join our team as a Senior Quality Systems Auditor at our manufacturing site in South Carolina.
This pivotal role involves conducting internal audits to ensure compliance with industry standards and regulations across the development, manufacturing, and distribution processes of medical devices.
Key Responsibilities:
- Conduct internal audits to ensure quality standards are met.
- Implement relevant regulations within organizational processes.
- Identify and address nonconformances, ensuring corrective actions are effective.
- Prepare and distribute detailed audit reports.
- Travel as necessary to various locations.
- Monitor and analyze quality audit data for trends.
- Evaluate processes and collaborate to find improvement opportunities.
- Work with process owners to ensure compliance with internal quality management system requirements.
Requirements:
- Bachelor's degree required.
- Minimum of 5 years of experience in quality auditing.
- Certification as a Quality Auditor or Lead Auditor is essential.
Expertise:
- Strong understanding of quality auditing principles and GxP best practices.
- Familiarity with process improvement methodologies (e.g., PDCA, DMAIC).
- In-depth knowledge of international regulations and quality standards for medical devices (ISO 13485, MDSAP, EU MDR).
- Advanced expertise in GxP best practices.
This position provides an opportunity for an experienced professional to champion the highest standards of quality and compliance in an innovative and progressive environment.
