Quality Systems Engineer: CAPA Leader & Compliance Expert

deka; Richmond (NH); On-site; USD 110,000 - 140,000; Full time

Job summary

DEKA Research and Development in New Hampshire is seeking a Quality Systems Engineer to strengthen our QMS across CAPA, change controls, and compliance with FDA QSR and ISO 13485.

You will own end-to-end CAPA processes, drive cross-functional remediation, and mentor teammates in root cause analysis while ensuring audit readiness and robust documentation.

Join a collaborative team near Boston with opportunities to influence medical device quality on cutting-edge projects.

Qualifications

• BS/MS in Engineering, Life Sciences, or related field.
• 3+ years in a quality systems role in a regulated industry.
• Experience with FDA QSR (21 CFR Part 820) and ISO 13485.
• Proficient in Excel, Word, and Visio; fast learner.
• Strong verbal and written communication; documentation skills.
• Experience with project coordination and technical writing.

Responsibilities

• Own end-to-end CAPA process from intake to verification.
• Facilitate cross-functional CAPA review meetings and remediation.
• Ensure CAPA evidence, problem statements, and traceability.
• Maintain CAPA documentation for audit readiness and risk linkage.
• Monitor CAPA trends and drive continuous improvement.
• Support training and mentorship on CAPA and root cause analysis.
• Develop and revise SOPs and change controls for QMS.
• Ensure compliance with FDA and ISO requirements.
• Develop knowledge of DEKA QMS processes for improvements.
• Review and approve quality records; promote data integrity.
• Conduct internal audits and support auditor training.
• Assist with external audits (FDA, ISO, customers) and responses.

Skills

Technical writing

Regulatory knowledge

Cross-functional collaboration

Problem solving

Attention to detail

Project coordination

Communication skills

Education

BS/MS in Engineering

Life Sciences background

Tools

Microsoft Excel

Microsoft Word

Visio

Job description

DEKA Research and Development in New Hampshire is seeking a Quality Systems Engineer to strengthen our QMS across CAPA, change controls, and compliance with FDA QSR and ISO 13485.

You will own end-to-end CAPA processes, drive cross-functional remediation, and mentor teammates in root cause analysis while ensuring audit readiness and robust documentation.

Join a collaborative team near Boston with opportunities to influence medical device quality on cutting-edge projects.