Senior Level Software QA Engineer Jobs
Senior level software qa engineer jobs place engineers at the center of quality strategy, owning test architecture, defining standards, and leading the teams that ship reliable software at scale. Openings are concentrated across Biotechnology & Pharmaceuticals, Healthcare & Medical Services, and Technology & Software, with 25% offering remote or hybrid arrangements and employers like Medpace, Fortinet, and Veracyte hiring at this level now.
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- 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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Top Industries Hiring
- Biotechnology & Pharmaceuticals
- Healthcare & Medical Services
- Technology & Software
- Consulting & Professional Services
Senior Level Software QA Engineer Jobs: Frequently Asked Questions
How do I get a senior level software qa engineer job?
Employers at this level expect candidates who have owned test strategy end to end, not just executed test plans. Demonstrate experience building automation frameworks from scratch, mentoring junior engineers, and influencing release decisions. Strong candidates also show they can communicate quality risk clearly to product and engineering leadership, and have led cross-functional efforts that improved defect detection or reduced production incidents.
Which companies hire senior level software qa engineers?
Companies hiring senior level software qa engineers right now include Medpace, Fortinet, and Veracyte, based on current listings on Migrate Mate as of November 2026. Hiring at this level covers large technology companies, fintech and healthcare software firms, and established enterprises investing in engineering quality programs.
Are there remote senior level software qa engineer jobs?
Yes, remote availability is strong at this level. About 25% of senior level software qa engineer openings are remote or hybrid as of November 2026, reflecting how many engineering organizations operate distributed quality teams. Senior roles are well suited to remote work because they rely on async collaboration, documented standards, and tooling that functions independently of a physical office.
What makes a software qa engineer role senior level?
Senior level software qa engineer roles are defined by ownership and scope rather than task completion. Engineers at this level design and maintain test automation infrastructure, set quality standards across a product or platform, review and guide the work of other engineers, and engage directly with product and engineering leads on release readiness. The role shifts from executing a test plan to authoring the strategy behind it.
Which industries hire the most senior level software qa engineers?
Senior level software qa engineer 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 because they operate complex, high-stakes software products where quality failures carry significant business or compliance consequences, creating demand for engineers who can own quality at an organizational level.