Quality Assurance Specialist

Job Summary

A company is looking for a Quality Assurance Specialist responsible for managing quality assurance processes and ensuring compliance with regulatory standards.

Key Responsibilities

• Conduct quality assurance audits and facilitate internal and supplier audits, following up on CAPAs and observations
• Maintain the Document Control System and ensure compliance with regulatory requirements and quality management standards
• Manage the Corrective Action and Preventive Action process, including root cause investigations and trend reporting

Required Qualifications

• Bachelor's degree in a technical, scientific, or business-related discipline preferred
• 3 years of related work experience in the medical device industry
• Knowledge of medical terms and Medical Device Reporting regulations
• Able to work independently with minimal supervision
• Exceptional organizational skills