Quality Assurance Manager

Job Summary

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

Key Responsibilities

• Develop, implement, and maintain Quality System Documents to ensure compliance with regulatory standards
• Support audits and regulatory inspections by providing expertise in Quality Assurance and Regulatory Affairs
• Participate in product development phases and manage Nonconforming Product and Complaint Processes

Required Qualifications and Education

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