Vice President of Software QA
1 week ago
Vice President of Software Quality Assurance – SaMD
X4 Life Sciences is working with an innovative Software as a Medical Device (SaMD) startup in Boston, MA seeking a Vice President of Software Quality Assurance to lead their quality strategy. This is a key leadership opportunity to ensure the highest levels of software quality and regulatory compliance.
The Role:
- Define and implement the overall QA strategy for SaMD products, ensuring compliance with FDAISO 13485IEC 62304, and other relevant standards.
- Oversee all aspects of software testing, validation, and risk management to ensure product safety and efficacy.
- Build and lead a high-performing QA team, collaborating with engineering, regulatory, and product development teams.
- Manage internal and external audits, ensuring rigorous quality processes across the product lifecycle.
Requirements:
- Extensive experience in Software Quality Assurance within the medical device or SaMD space.
- Strong knowledge of medical device regulations, with a proven track record in scaling QA processes.
- Excellent leadership and communication skills, with the ability to drive cross-functional collaboration.
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