We are working with an innovative medical technology company on a mission to make heart disease diagnosis and management faster, smarter, and more accessible through innovative digital solutions.

About the Role
We're seeking a Quality Assurance Associate to join the team. In this role, you will manage and execute key quality processes, including CAPA, NCR, complaint handling, feedback analysis, and post-market surveillance (PMS). You will ensure compliance with ISO 13485 and FDA 21 CFR Part 820, provide data-driven insights, and maintain audit-ready documentation that supports our ongoing compliance and continuous improvement initiatives.

Key Responsibilities

• Manage CAPA, NCR, complaints, and feedback processes — from investigation through to documentation and closure.
• Conduct post-market surveillance, trend analysis, and prepare regulatory reports to relevant authorities.
• Generate reports and dashboards to communicate quality metrics and CAPA effectiveness.
• Support QMS documentation, internal audits, and training activities.
• Collaborate with cross-functional teams to ensure quality requirements are met and drive continuous improvement.

About You

• Bachelor's degree in Biomedical Engineering, Quality Assurance, Regulatory Affairs, or a related discipline.
• Minimum 3 years' experience in a Quality Assurance role within the medical device industry.
• 2 years + experience managing post market surveillance activities and complaint handling in compliance with ISO 13485 and FDA 21 CFR Part 820 (≥ 2 years)
• Current knowledge of global medical device regulations, including EU MDR (2017/745) and FDA MDR
• Good understanding of quality system regulations (ISO 13485, 21 CFR 820) and risk management standards (ISO 14971).
• Experience with Software as a Medical Device (SaMD) is highly desired.

How to Apply
If you're a detail-oriented QA professional looking to make an impact, we'd love to hear from you.
You can send your resume to [email protected] or [email protected].