Senior Level Software Quality Assurance Jobs
Senior level software quality assurance jobs place experienced professionals in charge of quality strategy, test architecture, and the engineering standards that entire product teams depend on. Roles are spread across on-site, remote, and hybrid settings in Biotechnology & Pharmaceuticals, Healthcare & Medical Services, and Technology & Software, with employers like Medpace, Fortinet, and Veracyte hiring at this level now.
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Showing 5 of 6+ Senior Level Software Quality Assurance jobs
- As a Senior Design Quality Engineer (DQE) for our medical device manufacturer client in the Greater Boston region, you will be responsible for ensuring end to end design quality and compliance across the product development lifecycle for Class II/III medical devices, including software-driven and active implantable products.
- Working directly with cross-functional teams, you will drive adherence to design controls, risk management, and SDLC best practices from concept through commercialization and post market activities.
In this role you will play a key role in:
- Serving as the quality lead on product development teams, ensuring compliance with design controls across all lifecycle phases (planning, inputs/outputs, verification, validation, transfer, and change management)
- Establishing and maintaining DHF, DMR, and DHR, ensuring complete traceability from user needs through verification and validation evidence
- Leading and maintaining risk management activities (hazard analysis, FMEA, risk files) and ensuring integration of risk controls into design and validation activities
- Providing quality oversight of software SDLC activities, ensuring compliance with applicable standards (e.g., IEC 62304) and integration with system-level risk management
- Reviewing and approving design, software, and validation deliverables to ensure completeness, consistency, and audit readiness
- Supporting verification, validation, and design transfer activities, ensuring alignment between design outputs and production processes
- Leading or supporting CAPA, nonconformance investigations, and root cause analysis to drive continuous improvement
- Supporting internal and external audits (FDA, Notified Body, ISO), and contributing to regulatory submissions (e.g., IDE, PMA, EU MDR)
- 10+ years of experience in Quality Engineering supporting regulated medical device development (Class II/III preferred)
- Strong hands on experience with design controls, DHF management, and traceability in regulated environments
- Working knowledge of applicable standards and regulations (e.g., 21 CFR 820, ISO 13485, ISO 14971, IEC 62304)
- Experience supporting software quality within the SDLC and understanding of software risk management principles
- Proven experience with risk management tools (e.g., FMEA, hazard analysis) and integration into product development
- Experience supporting audits and regulatory submissions, with the ability to defend design and quality documentation
- Strong analytical, documentation, and communication skills with ability to work effectively across cross-functional teams
- Experience with quality systems, eQMS/PLM tools, and defect/CAPA management processes
- As a Senior Design Quality Engineer (DQE) for our medical device manufacturer client in the Greater Boston region, you will be responsible for ensuring end to end design quality and compliance across the product development lifecycle for Class II/III medical devices, including software-driven and active implantable products.
- Working directly with cross-functional teams, you will drive adherence to design controls, risk management, and SDLC best practices from concept through commercialization and post market activities.
In this role you will play a key role in:
- Serving as the quality lead on product development teams, ensuring compliance with design controls across all lifecycle phases (planning, inputs/outputs, verification, validation, transfer, and change management)
- Establishing and maintaining DHF, DMR, and DHR, ensuring complete traceability from user needs through verification and validation evidence
- Leading and maintaining risk management activities (hazard analysis, FMEA, risk files) and ensuring integration of risk controls into design and validation activities
- Providing quality oversight of software SDLC activities, ensuring compliance with applicable standards (e.g., IEC 62304) and integration with system-level risk management
- Reviewing and approving design, software, and validation deliverables to ensure completeness, consistency, and audit readiness
- Supporting verification, validation, and design transfer activities, ensuring alignment between design outputs and production processes
- Leading or supporting CAPA, nonconformance investigations, and root cause analysis to drive continuous improvement
- Supporting internal and external audits (FDA, Notified Body, ISO), and contributing to regulatory submissions (e.g., IDE, PMA, EU MDR)
- 10+ years of experience in Quality Engineering supporting regulated medical device development (Class II/III preferred)
- Strong hands on experience with design controls, DHF management, and traceability in regulated environments
- Working knowledge of applicable standards and regulations (e.g., 21 CFR 820, ISO 13485, ISO 14971, IEC 62304)
- Experience supporting software quality within the SDLC and understanding of software risk management principles
- Proven experience with risk management tools (e.g., FMEA, hazard analysis) and integration into product development
- Experience supporting audits and regulatory submissions, with the ability to defend design and quality documentation
- Strong analytical, documentation, and communication skills with ability to work effectively across cross-functional teams
- Experience with quality systems, eQMS/PLM tools, and defect/CAPA management processes
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Who's Hiring
Top Industries Hiring
- Biotechnology & Pharmaceuticals
- Healthcare & Medical Services
- Technology & Software
- Consulting & Professional Services
Senior Level Software Quality Assurance Jobs: Frequently Asked Questions
How do I get a senior level software quality assurance job?
Employers hiring at this level look for candidates who have owned test strategy end-to-end, not just executed it. Demonstrated experience designing automation frameworks from scratch, identifying systemic quality gaps, and influencing engineering culture gives a strong edge. Showing that you have mentored junior testers and partnered directly with product and engineering leadership signals the ownership mindset these roles require.
Which companies hire senior level software quality assurances?
Companies hiring senior level software quality assurances right now include Medpace, Fortinet, and Veracyte, based on current listings on Migrate Mate as of November 2026. Hiring at this level tends to concentrate in large technology companies, enterprise software firms, and regulated industries like financial services and healthcare that require rigorous quality oversight.
Are there remote senior level software quality assurance jobs?
Yes, remote and hybrid availability is strong at this level. About 25% of senior level software quality assurance openings are remote or hybrid as of November 2026, reflecting how many engineering organizations have normalized distributed quality teams. Senior roles in particular often remain flexible because the work centers on strategy and collaboration rather than physical lab environments.
What makes a software quality assurance role senior level?
Senior level software quality assurance roles are defined by scope, ownership, and influence. You are expected to design and govern the overall test strategy, make architectural decisions about tooling and automation infrastructure, and set quality standards for the broader engineering organization. Mentoring junior and mid-level QA engineers and driving alignment between QA, product, and development are core responsibilities, not secondary ones.
Which industries hire the most senior level software quality assurances?
Senior level software quality assurance roles concentrate in Biotechnology & Pharmaceuticals, Healthcare & Medical Services, and Technology & Software, based on current listings on Migrate Mate as of November 2026. These sectors drive hiring at this level because they ship complex, high-stakes software at scale and need experienced quality leaders who can enforce standards across large, fast-moving engineering organizations.