Software Quality Assurance Lead (Senior Manager / Director)

Company Description

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
• Experience supporting audits and regulatory inspections

Preferred:

• Experience with Software as a Medical Device (SaMD), Software in a Medical Device (SiMD), or other regulated digital health products
• Familiarity with the iterative planning and execution of SQA activates in an Agile or hybrid development methodologies in regulated environments.
• Experience with test automation frameworks and CI/CD pipelines.
• Knowledge of cybersecurity and data integrity requirements for medical software

You Deeply Identify with Core Detect Values:

• Put people first. Our colleagues and our customers come first. We respect each other and celebrate our diversity. We take joy in each other’s success, and succeed or fail as a team
• Eye of the owner. We have an ownership mindset and take responsibility for all of our decisions. No problem is someone else's problem. We are frugal and use company resources as if they were our own
• No genius without grit. As innovators, we fail often but fast. We are tenacious. We push through adversity and keep getting up. We are problem solvers and always find a way
• Err on the side of doing. We are scrappy and biased toward action — everyone is an individual contributor. We allow intuition to guide us when we have imperfect information
• Move fast by working smart. We are inventors. We focus, plan, pursue, and adjust to make big things happen in a fraction of the time others can. We disagree and commit
• Always be frank. We celebrate openness and diversity of opinion. We are transparent and candid but compassionate in our feedback, and are always honest to ourselves and our customers

Additional Information

We offer great perks:

• Fully covered medical insurance plan, and dental & vision coverage - as a health-tech company, we place great worth on our teams’ well-being
• Competitive salaried compensation - we value our employees and show it
• Equity - we want every employee to be a stakeholder
• Pre-tax commuter benefits - we make your commute more reasonable
• 401k plan - we facilitate your retirement goals
• Beautiful office near the ocean-front in historic Guilford, Connecticut
• The opportunity to build a revolutionary healthcare product and impact millions of lives!

For this role, we provide visa assistance for qualified candidates.

Detect does not accept agency resumes.

Detect is an E-Verify and equal opportunity employer regardless of race, color, ancestry, religion, gender, national origin, sexual orientation, age, citizenship, marital status, disability or Veteran status. All your information will be kept confidential according to EEO guidelines.