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.