Quality Systems Engineer: CAPA & Process Improvement Leader

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

Job summary

DEKA Research & Development is seeking a Quality Systems Engineer to join our collaborative team. You will own the CAPA process, drive regulatory compliance, and support QMS improvements with cross-functional teams.

You will ensure FDA QSR (21 CFR Part 820) and ISO 13485 alignment, develop SOPs, and mentor teammates in CAPA best practices and root cause analysis. Strong writing and coordination skills are essential for success.

Qualifications

• BS/MS in Engineering, Life Sciences, or related field.
• 3+ years in a quality systems role in a regulated industry (medical devices preferred).
• 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 including intake, triage, investigation, root cause analysis, corrective/preventive action planning, and verification of effectiveness.
• Facilitate cross-functional CAPA review meetings to identify issues and remediation strategies.
• Ensure CAPA documentation has objective evidence and traceability to processes, products, or records.
• Maintain CAPA documentation for regulatory readiness, timely closures, and risk linkage.
• Monitor CAPA trends and metrics to drive continuous improvement.
• Support training on CAPA expectations, best practices, and root cause analysis tools.
• Develop and revise SOPs and change controls to align with regulatory requirements and QMS.
• Ensure ongoing compliance with FDA 21 CFR Part 820 and ISO 13485.

Skills

Technical writing

Curiosity

Clear communication

Project coordination

Problem solving

Collaborative

Attention to detail

Reliability

Education

BS/MS in Engineering or Life Sciences

Tools

Excel

Word

Visio

Job description

DEKA Research & Development is seeking a Quality Systems Engineer to join our collaborative team. You will own the CAPA process, drive regulatory compliance, and support QMS improvements with cross-functional teams.

You will ensure FDA QSR (21 CFR Part 820) and ISO 13485 alignment, develop SOPs, and mentor teammates in CAPA best practices and root cause analysis. Strong writing and coordination skills are essential for success.