Quality Assurance Manager

Job Summary

A company is looking for a Manager of Quality Assurance & Regulatory Affairs.

Key Responsibilities

• Develop and maintain Quality System Documentation to ensure compliance with regulatory standards
• Participate in audits and provide expertise on Quality Assurance and Regulatory Affairs topics
• Coordinate the collection and analysis of data for CAPA, Complaints, and Clinical Evaluation for management reviews

Required Qualifications

• Bachelor's degree in Healthcare, IT, Quality, or related field (or equivalent experience)
• Minimum 5 years of experience in managing Quality Assurance/Regulatory Affairs in a medical device company
• Minimum 5 years of experience with FDA and international regulatory guidance
• Proven compliance with standards such as MDSAP, MDR, UKCA, ISO 13485, and QMSR
• Strong understanding of risk assessment processes