Software Quality Assurance Engineer - medical device

Published: 6/14/2022

Technology

Job Description

InnoTECH Staffing is seeking a technically savvy, automation-minded Software Quality Assurance Engineer to join an innovative cloud engineering team onsite in Manchester, NH.

This is an exciting opportunity for a software professional who understands that great engineering isn't just about writing great code — it's about building the processes, tools, and quality systems that make exceptional software development repeatable, scalable, and successful.

You'll work at the intersection of cloud-native engineering, software quality, automation, and regulatory compliance, partnering directly with development teams to transform how software is documented, verified, and delivered. Your mission will be to take complex regulatory requirements and turn them into practical, streamlined engineering workflows that make quality an integrated part of development — not an administrative burden.

You'll embed with cloud engineering teams, understand their technologies and development practices, identify opportunities to automate and standardize, and establish documentation frameworks that can scale across multiple product teams.

From software architecture and requirements traceability to automated testing, risk management, cybersecurity, and release readiness, you'll play a critical role in creating the infrastructure that enables developers to focus on innovation while ensuring the organization maintains the highest standards of software quality and regulatory compliance.

This is an individual contributor role with significant organizational influence. You won't be managing people — you'll be leading through technical expertise, collaboration, credibility, and the ability to make good processes work for the people who use them.

If you're a software engineer at heart who loves automation, understands regulated environments, and gets excited about making engineering teams more effective, this is an opportunity to make a meaningful impact.

Please note: This is a fully onsite position in Manchester, NH. Remote and hybrid arrangements are not available.

How You'll Make an Impact

You'll help establish the quality and documentation foundation that allows cloud engineering teams to move faster, work smarter, and deliver confidently in a regulated environment.

Transform Engineering Best Practices: Embed with cloud-native engineering teams to understand their development workflows, documentation practices, and automation tools. Turn what works into standardized templates, work instructions, and SOPs that can be adopted across similar product teams.
Own the Software Quality Documentation Lifecycle: Take the lead in creating and maintaining critical software lifecycle documentation, including Software Development Plans (SDPs), Software Requirements Specifications (SRS), Software Design Documents (SDDs), Verification & Validation Plans and Reports, and Software Risk Management Files.
Make Compliance Part of the Engineering Workflow: Champion automation-first, DevSecOps-oriented quality practices that integrate documentation, verification, and regulatory compliance into the software development lifecycle.
Drive Change Control and Release Readiness: Coordinate document change control from initiation through review and approval, ensuring documentation activities stay aligned with engineering priorities and release schedules.
Build End-to-End Traceability: Establish and maintain traceability matrices connecting requirements, software design elements, risk controls, test cases, and defects — ensuring objective evidence is complete, accurate, and audit-ready.
Keep Releases Moving: Own the documentation project plan for each software release, tracking deliverables, review cycles, open items, and approval milestones alongside the engineering release schedule.
Champion Quality Before It Becomes a Bottleneck: Lead documentation readiness reviews ahead of design freezes, test execution, and regulatory submission milestones. Identify gaps early, communicate risks, and work directly with engineering leads to resolve issues before they impact delivery.
Influence Across Teams: Become a trusted technical resource who helps developers understand regulatory expectations and helps quality and regulatory stakeholders understand modern cloud engineering practices.

What You'll Bring to the Team

We're looking for someone who combines strong software engineering knowledge with a passion for quality, automation, and well-designed processes.

Education & Experience

Bachelor's degree in Computer Science, Software Engineering, or a closely related technical discipline required.
Advanced degree or professional certifications such as ASQ CSQE, ISTQB, or RAC are a plus.
5–8 years of combined experience in software quality engineering, software development, or a closely related technical role.
At least 2 years of experience in an FDA-regulated environment preferred, such as medical devices, digital health, or pharmaceutical software.

Technical & Regulatory Expertise

A hands-on software development background with the ability to read, understand, and evaluate Go, Java, or Python code, Infrastructure-as-Code (Terraform, Ansible), and automated test code (Playwright, pytest).
Demonstrated experience developing IEC 62304-compliant documentation for Class B or Class C software.
Practical knowledge of ISO 14971 risk management as applied to medical device software, including experience authoring or contributing substantially to FMEAs and software hazard analyses.
Working knowledge of FDA cybersecurity expectations for medical devices, including familiarity with NIST frameworks and evaluating cloud-hosted systems against relevant security expectations.
Familiarity with cloud-native architectures, including microservices, event-driven systems, networking, and identity and access management (IAM).
Direct experience writing automated tests using Python or Go, or developing UI and end-to-end test automation with Playwright.

The Qualities That Will Make You Successful

Beyond your technical background, we're looking for someone who brings the right mindset to a role that requires influence, initiative, and collaboration.

Automation is your first instinct. You naturally look for ways to replace repetitive manual activities with scalable, repeatable solutions — and understand how automation strengthens both engineering efficiency and regulatory defensibility.
You speak both engineering and regulatory. You can confidently discuss architecture and automated testing with software developers while translating regulatory expectations into practical requirements and documentation.
You believe documentation is engineering. You understand that precision, clarity, version control, and traceability are fundamental to building safe, reliable, and compliant software.
You're a natural collaborator. You enjoy working alongside developers, quality professionals, and regulatory stakeholders to solve problems and improve how teams operate.
You take ownership. You're comfortable working independently across multiple teams, managing competing priorities, and driving projects forward without needing formal authority.
You see the bigger picture. You don't just check boxes or maintain documents. You understand how the right quality systems, tools, and processes can fundamentally improve the way an engineering organization delivers software.

Why This Opportunity?

This is your chance to have an impact well beyond a single software team.

You'll help shape the way an organization develops and delivers cloud-native software in a regulated environment. You'll have the opportunity to work with modern technologies, influence engineering workflows, introduce smarter automation practices, and build scalable quality systems that benefit multiple teams and future product releases.

Rather than simply policing compliance, you'll help make compliance easier, smarter, and more integrated into the engineering process.

If you're a technically strong software professional who loves automation, thrives on solving complex problems, and wants to redefine what software quality looks like in a modern cloud engineering environment, we'd love to connect with you!

Bring your engineering mindset. Drive smarter quality.