Senior Quality Engineer

Senior Quality Engineer - SaMD Start-Up in Boston X4 Life Sciences is partnered with a start-up in Boston that specializes in Software as a Medical Device (SaMD) solutions. This dynamic company is developing advanced patient monitoring systems that integrate seamlessly with physical devices to enhance clinical decision-making. We're looking for a Senior Quality Engineer who is passionate about quality assurance in the medical device space. About the Company: This fast-growing start-up is committed to revolutionizing patient care through innovative software solutions that meet the highest regulatory standards. As a Senior Quality Engineer, you will play a crucial role in ensuring their products are safe, effective, and of the highest quality. Role Overview: You will develop and implement quality assurance processes throughout the product lifecycle and work closely with cross-functional teams to ensure compliance with regulatory requirements. Key Responsibilities: Quality Assurance: Create and execute quality plans, risk assessments, and validation protocols to meet FDA and ISO standards. Process Improvement: Identify areas for enhancement and implement best practices to drive continuous quality improvement. Collaboration: Work with engineering, product management, and regulatory teams to ensure quality is integrated throughout development. Ideal Candidate: Experience: 5+ years in quality engineering within the medical device industry. Technical Knowledge: Strong understanding of FDA regulations, ISO 13485, and SaMD challenges. Problem-Solving Skills: Excellent analytical skills with a proven track record of identifying issues and implementing effective solutions.

Created: 2024-10-30