ctDNA Diagnostic Quality Engineer

Our Client is an early-stage, venture-backed, molecular diagnostic company that is developing non-invasive cancer detection leveraging ultra-sensitive tests for various cancers to identify MRD at levels below the detection limit of today's existing technologies.

The Software Quality Engineer position involves overseeing the quality of software systems supporting various teams and products within the company, ensuring adherence to relevant standards and regulations. Collaboration with internal departments like clinical laboratory, R&D, product development, and regulatory teams will be essential. Additionally, participation in regulatory audits is expected. This is a full-time role with flexibility in working hours, reporting to the Director of Quality.

Responsibilities:

• Develop and implement comprehensive test plans for product compliance, coordinating with various teams.
• Execute test plans, both automated and manual, and present findings to leadership for review.
• Lead validation plan development for software systems.
• Create and update SOPs to define software quality requirements.
• Develop risk analysis tools and management plans for software systems.
• Monitor and enhance process efficiency through audits and reporting.
• Manage end-user issues, including NCR and CAPA processes.
• Ensure adherence to company SOPs and regulatory requirements in software quality practices.

Qualifications:

• 3-5 years of experience in software quality within regulated environments (e.g., FDA, ISO, CAP/CLIA).
• Bachelor’s degree in software engineering, computer science, or related field.
• Proficiency in executing IEC62304 software design lifecycle in alignment with ISO13485 requirements.
• Experience in defining and conducting software validation processes.
• Ability to oversee software test execution (both automated and manual).
• Strong problem-solving skills with a track record of delivering actionable results.
• Capability to manage end-to-end projects autonomously.
• Excellent interpersonal skills for collaborative work across diverse teams.