> Markdown version of [/jobs/ext/1803581-quality-systems-engineer-capa-and-process](https://www.wearedevelopers.com/jobs/ext/1803581-quality-systems-engineer-capa-and-process). 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). --- # Quality Systems Engineer - CAPA and Process... - **Company:** DEKA Research & Development - **Location:** Manchester, NH, United States - **Experience:** Experienced - **Contract:** Permanent contract - **Skills:** Microsoft Word, Microsoft Excel, Microsoft Visio - **Published:** July 2, 2026 - **Apply:** https://www.juju.com/job/00000000gdkz6h ## About the Role + Strong technical writing skills: you can translate complex concepts clearly for diverse audiences. + A natural curiosity and ability to quickly grasp technical systems, workflows, and requirements. + Clear, confident communication: you know how to explain problems and solutions across a range of technical backgrounds. + Solid project coordination and follow-through: you're organized, dependable, and keep work moving forward. + A proactive problem-solver mindset: you ask the right questions, challenge assumptions, and help teams find solutions. + Collaborative energy: you contribute, share ideas, and maintain a constructive, can-do attitude. + Precision and attention to detail: your work is thorough and consistent. + Reliability: you take ownership, meet deadlines, and follow through. Required Training / Knowledge: + BS/MS in Engineering, Life Sciences, or a related field + 3+ years of experience in a quality systems role in a regulated industry, ideally medical devices + Working knowledge of FDA QSR (21 CFR Part 820) and ISO 13485 + Proficiency with Microsoft Excel, Word, and Visio (or ability to learn quickly) + Strong verbal and written communication skills + Experience in project coordination and technical writing ## Description Join our dynamic team at DEKA and be at the forefront of driving quality excellence! As our Quality Systems Engineer, you'll be a key player in our collaborative environment, working hand-in-hand with cross-functional teams to ensure the highest standards of quality and compliance. As a Quality Systems Engineer, you will contribute in the following areas: + Own and manage the end-to-end CAPA process, from intake and triage through investigation, root cause analysis, corrective/preventive action planning, and effectiveness verification. + Facilitate cross-functional CAPA review meetings, ensuring teams identify systemic issues and align on appropriate remediation strategies. + Ensure each CAPA is supported with objective evidence, clear problem statements, and traceability to impacted processes, products, or quality records. + Maintain CAPA documentation in alignment with regulatory expectations, ensuring timely closure, audit readiness, and linkage to risk management where applicable. + Monitor CAPA trends and performance metrics to identify recurring issues and drive continuous improvement. + Support training and mentorship of team members on CAPA expectations, best practices, and root cause analysis tools. + Own the development and revision of Standard Operating Procedures (SOPs) and associated change controls to ensure they align with regulatory requirements and support QMS compliance. + Ensure ongoing compliance with FDA 21 CFR Part 820 and ISO 13485, maintaining the integrity and effectiveness of the DEKA QMS. + Develop a strong working knowledge of DEKA's QMS processes and use this expertise to identify and implement system improvements. + Review and approve quality records, ensuring accuracy, completeness, and adherence to applicable requirements. + Conduct internal audits and support auditor training efforts to promote audit readiness and compliance with regulatory requirements. + Support external audits (e.g., FDA, ISO, customer audits) by preparing documentation, facilitating audit logistics, and responding to auditor requests in real time. ## Related Videos - [Great DevEx and Regulatory Compliance - Possible?](https://www.wearedevelopers.com/videos/1426-great-devex-and-regulatory-compliance-possible) - [In-depth .NET Azure Functions: Isolated mode, performance and durable AI agents](https://www.wearedevelopers.com/videos/100207-in-depth-net-azure-functions-isolated-mode-performance-and-durable-ai-agents) - [Developing the Rich Text Editor for DeepL.com](https://www.wearedevelopers.com/videos/1172-developing-the-rich-text-editor-for-deepl-com) - [Model Based Systems Engineering in an Agile Product Development Process](https://www.wearedevelopers.com/videos/68-model-based-systems-engineering-in-an-agile-product-development-process) - [From Syntax to Singularity: AI’s Impact on Developer Roles](https://www.wearedevelopers.com/videos/900-from-syntax-to-singularity-ai-s-impact-on-developer-roles) - [One Pipeline, Three Regulator - SBOM Compliance for the Developer](https://www.wearedevelopers.com/videos/100169-one-pipeline-three-regulator-sbom-compliance-for-the-developer) ## Related Articles - [Now is the time for industrialized software development](https://www.wearedevelopers.com/magazine/601-now-is-the-time-for-industrialized-software-development) - [What is Software Engineering?](https://www.wearedevelopers.com/magazine/289-what-is-software-engineering) - [Events like RSAC Get You CISOs. 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