Job Description

Quality Systems Senior Auditor

A leading global medical device company, renowned for its innovation in product development and medical education within orthopedics, is seeking a Senior Quality Systems Auditor for its 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. This is an exciting opportunity for a seasoned professional to contribute to the highest standards of quality and excellence in a dynamic and forward-thinking environment.

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.

Qualifications:

• 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 exhilarating opportunity for an experienced professional to champion the highest standards of quality and compliance in an innovative and progressive environment.

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