Senior Software QA Engineer

Adeptsource; United States; Remote; USD 140,000 - 180,000; Full time

Job summary

Adeptsource seeks a senior software compliance consultant to drive regulatory alignment for our medical device SaMD products. You will lead software validation, risk management, and design controls, partnering with product management, regulatory affairs, software systems engineering, operations, and quality to ensure FDA and ISO compliance.

This six-month remote engagement in the United States requires deep experience with FDA submissions (510(k)/PMA), IEC 62304, ISO 13485, and a proven track

Qualifications

• 10+ years in the medical device industry with strong knowledge of software validation practices, quality systems, regulatory submissions, and compliance requirements for a medical device (e.g., ISO 13485, IEC 62304).
• Deep knowledge of FDA regulations (21 CFR Part 820) for design controls and quality systems.
• Experience with HIPAA and FDA cybersecurity guidance on software risk controls and interoperability.
• Experience with ISO 14971 risk management and IEC 62304 lifecycle.
• Experience with FDA interactions (510(k), PMA) and inspections.
• Experience with Usability / Human Factors validation.
• Audits of ISO 13485 or FDA inspections is a plus.

Responsibilities

• Support product development per the software development life cycle, including adherence to requirements management, design, and development.
• Collaborate with cross functional teams to integrate bioinformatic and software innovations into diagnostic tools and workflows.
• Support the development and validation of algorithms and software solutions for medical device applications, ensuring compliance with regulatory and quality standards.
• Develop and implement software validation strategies including risk management per FDA, ISO, IEC 62304.
• Oversee system architecture and validation docs (plans, protocols, tests) to ensure regulatory compliance.
• Oversee software risk management (hazard analysis, risk assessment).
• Maintain lifecycle documentation (design specs, tests, risk analyses, traceability).
• Prepare tech docs and regulatory submissions (510(k)/PMA) and participate in FDA interactions.
• Act as SME in audits/reviews with authorities and partners; co-lead gap resolutions.
• Manage backlog prioritization based on roadmap and user needs.
• Support Human Factors testing and risk assessment per IEC 62366-1 and ISO 14971.

Skills

FDA submissions

Regulatory compliance

Software validation

Risk management

HIPAA compliance

Cybersecurity

ISO 14971

Quality systems

Cross-functional teamwork

Medical device

Education

BS/MS in software

Job description

This position will be responsible for driving compliance and implementing strategic vision for the software products and services developed. The position will partner with the Product Management Organization, assay development, regulatory affairs, software systems engineering, operations, and quality for development and maintenance of products in accordance with regulatory requirements and the software development life cycle. *This is a 6 month consultant role to be done remotely.

• The ideal candidate will have a strong background in product software engineering in molecular diagnostics or the medical device industry, with extensive experience with FDA submissions and working within cross functional teams to delivery product software for medical device and SaMD meeting regulatory requirements and will have experience interacting directly with the FDA.

Responsibilities

• Support product development per the software development life cycle, including adherence to requirements management, design, and development.
• Collaborate with key cross functional teams such as assay development, regulatory affairs, software systems engineering, and quality to integrate bioinformatic and software innovations into diagnostic tools and workflows.
• Support the development and validation of algorithms and software solutions for medical device applications, ensuring compliance with regulatory and quality standards.
• Develop and implement comprehensive software validation strategies to include risk management, ensuring alignment with regulatory requirements (FDA, ISO, IVDR, etc.) and company standards in accordance with IEC 62304 Medical device software - Software life cycle processes.
• In collaboration with Software Systems Engineering leadership, oversee the creation and maintenance of system architecture and all validation documentation, including validation plans, protocols, test scripts, and reports to ensure compliance to regulatory standards.
• Collaborate with Software Systems Engineering, Regulatory, and Quality leadership to oversee software risk management activities, including hazard analysis and risk assessment.
• Maintain detailed documentation throughout the software lifecycle, including design specifications, test results, risk analyses and traceability records for compliance and audits.
• Partner with cross functional teams to prepare technical documentation, reports, and regulatory submissions such as 510(k) or PMA and participate in FDA interactions.
• Participate as a product software subject matter expert in routine interactions, product reviews, or audits with government authorities, notified bodies, or partners and co-lead resolution strategies to address gaps or issues raised.
• Manage the product software backlog, prioritizing features and enhancements based on the product roadmap, user needs, business value, and technical feasibility.
• Support development of Human Factors files, including planning of human factors testing and risk assessment in accordance with IEC 62366-1 and ISO 14971.

Requirements

• Bachelor's or MS in Software Engineering, Computer Science, or a related field.
• 10+ years of experience in the medical device industry with strong knowledge of software validation practices, quality systems, regulatory submissions, and compliance requirements for a medical device (e.g., ISO 13485, IEC 62304).
• Deep understanding of FDA regulations such as 21 CFR Part 820 to support design controls, quality management systems, production processes, and more. Familiar with relevant FDA guidance documents for medical device software and SaMD.
• Experience in compliance with HIPAA and relevant FDA guidance on cybersecurity, software risk controls, interoperability, change control, human factors.
• Experience implementing robust risk management processes and tools throughout the software development process, following standards like ISO 14971.
• Expert level experience with software validation and verification processes, including writing and executing test protocols and reports.
• Proven track record of working with regulatory bodies such as the FDA (e.g., 510(k), PMA, or Breakthrough Device Designation), to include direct interaction.
• Experience with planning and execution on Usability / Human Factors validation.
• Previous experience conducting or supporting ISO 13485 audits or supporting FDA inspections a plus.
• Strong interpersonal and communication skills, with the ability to work effectively in cross-...discrete lists....l...but....??
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