> Markdown version of [/jobs/ext/170392-senior-design-quality-engineer](https://www.wearedevelopers.com/jobs/ext/170392-senior-design-quality-engineer). Every page supports `.md` or `Accept: text/markdown`. Links point to the HTML versions so they work for humans too. Agent guide: [/agents.md](https://www.wearedevelopers.com/agents.md).

---

# Senior Design Quality Engineer

- **Company:** Capgemini
- **Location:** Burlington, MA, United States
- **Experience:** Expert
- **Salary:** $73,150.0 - $146,300.0
- **Contract:** Permanent contract
- **Skills:** Software Quality, Failure Mode Effects Analysis, Systems Development Life Cycle, Verification and Validation (Software)
- **Published:** May 17, 2026
- **Apply:** https://www.careerjet.com/jobad/us2e48d1f6d550c20dd17dd4b1542f582e

## About the Role

* 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

## Description

Capgemini Engineering are actively looking for Senior Design Quality Engineer with senior QA who will be 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)
Your role

 * 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)


## Related Videos

- [Quality Strategy with a side of Swiss Cheese](https://www.wearedevelopers.com/videos/467-quality-strategy-with-a-side-of-swiss-cheese)
- [Let's Talk Quality! - Lilia Gargouri](https://www.wearedevelopers.com/videos/1815-let-s-talk-quality-lilia-gargouri)
- [What Production Knows: Closing the Loop Between AI Agents and the Systems They Build](https://www.wearedevelopers.com/videos/100277-what-production-knows-closing-the-loop-between-ai-agents-and-the-systems-they-build)
- [Navigating the AI Revolution in Software Development](https://www.wearedevelopers.com/videos/1266-navigating-the-ai-revolution-in-software-development)
- [Let’s Talk Quality!](https://www.wearedevelopers.com/videos/100012-let-s-talk-quality)
- [The Affordances of Quality](https://www.wearedevelopers.com/videos/1134-the-affordances-of-quality)

## Related Articles

- [What is Software Engineering?](https://www.wearedevelopers.com/magazine/289-what-is-software-engineering)
- [Top Characteristics of a Software Engineer](https://www.wearedevelopers.com/magazine/166-top-characteristics-of-a-software-engineer)
- [The 12 Best Jobs for Software Engineers](https://www.wearedevelopers.com/magazine/401-the-12-best-jobs-for-software-engineers)
- [Now is the time for industrialized software development](https://www.wearedevelopers.com/magazine/601-now-is-the-time-for-industrialized-software-development)
- [Résumé-Driven Development: How IT trends affect the job market for software developers](https://www.wearedevelopers.com/magazine/59-resume-driven-development-how-it-trends-affect-the-job-market-for-software-developers)
- [What’s the Difference between a Junior, Mid, and Senior Developer?](https://www.wearedevelopers.com/magazine/238-what-s-the-difference-between-a-junior-mid-and-senior-developer)