Quality Assurance Manager
SaMD-Digital Health
X4 Life Sciences are proud to be partnered with an innovative SaMD company focused on developing digital health solutions to improve patient outcomes. We are seeking a Quality Assurance Manager to lead QA processes, ensuring compliance with regulatory standards and delivering high-quality software products.
Key Responsibilities:
- Manage QMS: Oversee the Quality Management System (QMS) in line with ISO 13485, IEC 62304, FDA 21 CFR Part 820, and other relevant standards.
- Software QA: Ensure software validation, verification, risk management, and testing comply with regulatory requirements.
- Regulatory Compliance: Lead internal audits, CAPAs, and non-conformance investigations. Ensure documentation is audit-ready.
- Team Leadership: Lead and mentor the QA team, providing training on regulatory standards and promoting continuous improvement.
- Risk Management: Implement risk management processes in accordance with ISO 14971.
Qualifications:
- 5+ years of QA experience in medical devices, SaMD, Digital Health.
- Expertise in ISO 13485, IEC 62304, FDA 21 CFR Part 820.
- Bachelor’s degree in Software Engineering, Quality Management, or a related field.
- Leadership, analytical, and problem-solving skills.