Quality Systems Engineer: CAPA, QMS & Compliance

DEKA Research & Development; United States; On-site; USD 90,000 - 130,000; Full time

Job summary

DEKA Research & Development is seeking a Quality Systems Engineer to lead CAPA, documentation, and QMS initiatives in a regulated environment. You will own end-to-end CAPA processes and partner with cross-functional teams to ensure traceability and audit readiness.

In this role you will drive continuous improvement, support FDA/ISO audits, and help develop SOPs and change controls that uphold DEKA’s QMS. Strong technical writing and problem-solving skills are essential.

Qualifications

• BS/MS in Engineering, Life Sciences, or related field required.
• Experience in a regulated industry (medical devices preferred).
• Strong writing and communication skills; audit readiness mindset.

Responsibilities

• Own and manage end-to-end CAPA process from intake to effectiveness verification.
• Facilitate cross-functional CAPA review meetings for remediation strategies.
• Ensure CAPA evidence, problem statements, and traceability to processes or records.
• Maintain CAPA documentation for regulatory expectations and audit readiness.
• Monitor CAPA trends and drive continuous improvement.
• Develop and revise SOPs and change controls for QMS compliance.
• Ensure ongoing FDA 21 CFR Part 820 and ISO 13485 compliance.
• Review quality records and support internal/external audits and training.

Skills

CAPA ownership

Technical writing

Cross-functional collaboration

Root cause analysis

Project coordination

Problem solving

Communication

Attention to detail

Education

BS/MS in Engineering, Life Sciences, or related field

Tools

Microsoft Excel

Microsoft Word

Visio

Job description

DEKA Research & Development is seeking a Quality Systems Engineer to lead CAPA, documentation, and QMS initiatives in a regulated environment. You will own end-to-end CAPA processes and partner with cross-functional teams to ensure traceability and audit readiness.

In this role you will drive continuous improvement, support FDA/ISO audits, and help develop SOPs and change controls that uphold DEKA’s QMS. Strong technical writing and problem-solving skills are essential.