Quality Systems Engineer: CAPA & Compliance Leader

DEKA Research & Development Corp.; Manchester (NH); On-site; USD 90,000 - 120,000; Full time

Job summary

DEKA Research & Development Corp. in Manchester, NH seeks a Quality Systems Engineer to strengthen our QMS and drive regulatory compliance across CAPA, SOPs, change controls, and audits.

You will partner with cross-functional teams to investigate issues, write clear quality records, and support FDA 21 CFR Part 820 and ISO 13485 requirements, ensuring timely closure and audit readiness. Strong writing, project coordination, and cross-functional collaboration are essential to success.

Qualifications

• 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

Responsibilities

• Own end-to-end CAPA process from intake to verification
• Facilitate cross-functional CAPA review meetings
• Ensure CAPA evidence and traceability
• Maintain CAPA docs for audit readiness
• Monitor CAPA trends and drive continuous improvement
• Support training on CAPA and root cause analysis
• Develop and revise SOPs and change controls
• Ensure compliance with FDA 21 CFR Part 820 and ISO 13485
• Develop knowledge of DEKA's QMS processes
• Review and approve quality records
• Conduct internal audits and auditor training
• Support external audits (FDA, ISO, customer) with docs

Skills

Technical writing

Project coordination

Verbal communication

Written communication

Education

BS/MS in Engineering

Tools

Excel

Word

Visio

Job description

DEKA Research & Development Corp. in Manchester, NH seeks a Quality Systems Engineer to strengthen our QMS and drive regulatory compliance across CAPA, SOPs, change controls, and audits.

You will partner with cross-functional teams to investigate issues, write clear quality records, and support FDA 21 CFR Part 820 and ISO 13485 requirements, ensuring timely closure and audit readiness. Strong writing, project coordination, and cross-functional collaboration are essential to success.