Quality Systems Engineer – CAPA and Process Improvement

DEKA Research & Development•Manchester, NH

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About The Position

DEKA is seeking a Quality Systems Engineer to drive quality excellence and support the integrity and effectiveness of its Quality Management System (QMS). The role owns the end-to-end Corrective and Preventive Action (CAPA) process, supports regulatory compliance with FDA 21 CFR Part 820 and ISO 13485, and identifies opportunities for system improvement. The engineer works collaboratively with cross-functional teams and contributes to documentation, audits, training, and continuous improvement.

Requirements

BS or MS in Engineering, Life Sciences, or a related field.
At least 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.
Strong technical writing, communication, project coordination, problem-solving, collaboration, attention to detail, and reliability.

Responsibilities

Own and manage the end-to-end CAPA process, from intake and triage through investigation, root cause analysis, corrective and preventive action planning, and effectiveness verification.
Facilitate cross-functional CAPA review meetings to identify systemic issues and agree on remediation strategies.
Ensure CAPAs have objective evidence, clear problem statements, and traceability to impacted processes, products, or quality records.
Maintain CAPA documentation in line with regulatory expectations, timely closure, audit readiness, and risk-management linkage where applicable.
Monitor CAPA trends and performance metrics to identify recurring issues and drive continuous improvement.
Support training and mentorship on CAPA expectations, best practices, and root cause analysis tools.
Develop and revise Standard Operating Procedures (SOPs) and associated change controls to align with regulatory requirements and support QMS compliance.
Maintain compliance with FDA 21 CFR Part 820 and ISO 13485 and support the integrity and effectiveness of DEKA’s QMS.
Develop knowledge of DEKA’s QMS processes and identify and implement system improvements.
Review and approve quality records for accuracy, completeness, and compliance with applicable requirements.
Conduct internal audits and support auditor training to promote audit readiness and regulatory compliance.
Support external FDA, ISO, and customer audits by preparing documentation, facilitating logistics, and responding to auditor requests in real time.