> Markdown version of [/jobs/ext/4416065-quality-systems-engineer](https://www.wearedevelopers.com/jobs/ext/4416065-quality-systems-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).

---

# Quality Systems Engineer

- **Company:** DEKA Research & Development
- **Location:** Manchester, NH, United States
- **Experience:** Experienced
- **Contract:** Permanent contract
- **Skills:** Microsoft Word, Microsoft Excel, Microsoft Visio, 21 CFR Part 820 Quality System Regulation
- **Published:** October 4, 2026
- **Apply:** https://www.juju.com/job/21_01a0e59a-366e-7e86-a10f-250460058aee

## 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.