Software Quality Assurance Lead; Senior Manager​/Director

Detect’s mission is to make accurate diagnostics accessible. We build breakthrough technology at the intersection of software, hardware, chemistry, and biology to make diagnostics available at the point of need. Our ultimate goal is to lower healthcare costs, improve patient outcomes, and improve doctor experience by enabling earlier diagnosis and access to treatment.

Job Description

The Software Quality Assurance Lead is responsible for leading the strategy, execution, and continuous improvement of software quality assurance processes in support of Detect’s regulated medical device products. This role ensures that all software development and validation activities meet the highest standards of quality, safety, and regulatory compliance, while enabling efficient and scalable product development.

This position requires deep expertise in software quality assurance within regulated environments, including experience with FDA and ISO standards, software validation, and risk management. The role combines strategic leadership and hands‑on execution, with responsibility for building and mentoring a high-performing QA team and partnering cross‑functionally with Engineering, Regulatory, Product, and Clinical teams.

In this role, the Software Quality Assurance Lead will drive and manage the development and implementation of compliant, scalable quality processes across the software lifecycle—from requirements management, design and development through verification, validation, design control, release, and change management. The individual will play a critical role in ensuring audit readiness, supporting regulatory submissions, and maintaining the integrity of the Quality Management System (QMS) as it relates to Software Quality Assurance.

As part of our team, your core responsibilities will be to:

• Lead and grow the Software QA team, providing mentorship, coaching, and performance management, including management of any contracted SQA resources, activities, or deliverables.
• Define and implement software quality strategies aligned with regulatory and business objectives.
• Establish and maintain Software Quality Assurance processes that support compliant and efficient product development.
• Ensure compliance with applicable standards and regulations, including FDA 21 CFR Part 820, Part 11, ISO 13485, and IEC 62304.
• Oversee software verification and validation (V&V) activities, including test planning, execution, and reporting.
• Ensure traceability between software requirements, risk controls, and verification activities.
• Drive risk‑based testing strategies in alignment with ISO 14971 and product safety requirements.
• Review and approve key software quality and validation deliverables, including test protocols, reports, and DHF artifacts.
• Partner with cross‑functional teams to embed quality throughout the software development lifecycle.
• Support internal and external audits, including FDA inspections and notified body audits.
• Drive continuous improvement of the QMS and software quality processes.
• Define and track software quality metrics (e.g., defect rates, test coverage, release readiness).
• Lead root cause investigations and CAPA activities for software‑related issues.
• Support the implementation and scaling of test automation and CI/CD quality practices.

Qualifications

Baseline skills, experiences, and attributes:

• Bachelor’s or Master’s degree in Computer Science, Engineering, or related field.
• 8–12+ years of experience in software quality assurance, with at least 5 years in a leadership role.
• Experience working in regulated environments such as medical devices, diagnostics, biotech, or pharmaceuticals.
• Strong knowledge of software quality and regulatory standards, including IEC 62304, FDA regulations, and ISO 13485.
• Experience with software verification and validation (V&V), including test planning, execution, and documentation.
• Familiarity with risk management practices (ISO 14971, FMEA, hazard analysis).
• Ability to develop and implement scalable QA processes in fast‑paced environments.
• Strong cross‑functional collaboration and communication skills.
• Detail‑oriented with a strong commitment to product quality and patient safety.
• Experien…