Senior Quality Assurance Analyst

Job Summary

Driving quality and compliance excellence, the full-time Senior Quality Assurance Analyst will manage CAPAs, support regulatory submissions, and ensure quality system execution while collaborating cross-functionally in a remote environment.

Key responsibilities

• Lead and manage Corrective and Preventive Actions (CAPAs) and drive improvements to the Quality Management System (QMS)
• Support internal and external audits to ensure compliance with regulatory and internal requirements
• Collaborate with cross-functional teams to integrate quality and regulatory requirements into development processes

Required qualifications

• Bachelor's degree in a scientific, engineering, or healthcare-related field, or equivalent industry experience
• 4+ years of experience in Quality Assurance and/or Regulatory Affairs within the medical device industry
• Demonstrated experience working within a certified Quality Management System (ISO 13485)
• Strong working knowledge of FDA 21 CFR Part 820 and ISO 14971 risk management principles
• Proven experience managing CAPA, audits, and supplier quality processes