DEKA Research & Development · 1 day ago
Quality Systems Engineer – CAPA and Process Improvement
Manchester, NH
Full-time
Onsite
Mid Level
3+ years expDEKA Research & Development is at the forefront of driving quality excellence and is seeking a Quality Systems Engineer. In this role, you will manage the CAPA process and ensure compliance with regulatory standards while collaborating with cross-functional teams to uphold quality and efficiency.
3D PrintingDeveloper PlatformManufacturingMedical Device
Responsibilities
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
Qualification
Required
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
Company
DEKA Research & Development
DEKA Research & Development provides technology solutions for power, mobility, and water applications along with fluid management.
501-1000 employees
H1B Sponsorship
DEKA Research & Development has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (13)
2024 (13)
2023 (23)
2022 (16)
2021 (9)
2020 (7)
Funding
Current Stage
Late StageLeadership Team
C
Chris Langenfeld
Chief Engineer of Advanced R&D
Thomas Bollenbach
Project Manager
Recent News
2025-10-10
NH Business Review
2025-03-26
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