Quality Systems Engineer: CAPA, Audits & QMS Lead

DEKA Research and Development; Manchester (NH); On-site; USD 80,000 - 100,000; Full time

Job summary

Join DEKA Research and Development as a Quality Systems Engineer in Manchester, NH, where you'll manage CAPA processes and ensure compliance with FDA and ISO standards. You'll work closely with various teams to maintain high-quality standards and facilitate effective audits.

The ideal candidate should have a BS/MS in Engineering or Life Sciences and 3+ years of relevant experience, along with strong technical writing and communication skills. DEKA is committed to driving quality excellence and fostering a collaborative work environment.

Qualifications

• 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.
• Strong verbal and written communication skills.

Responsibilities

• Own and manage the end-to-end CAPA process.
• Facilitate cross-functional CAPA review meetings.
• Maintain CAPA documentation in alignment with regulatory expectations.
• Support training and mentorship of team members on CAPA expectations.
• Ensure ongoing compliance with FDA and ISO standards.

Skills

Technical writing

Communication

Project coordination

Problem-solving

Attention to detail

Education

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

Tools

Microsoft Excel

Microsoft Word

Microsoft Visio

Job description

Join DEKA Research and Development as a Quality Systems Engineer in Manchester, NH, where you'll manage CAPA processes and ensure compliance with FDA and ISO standards. You'll work closely with various teams to maintain high-quality standards and facilitate effective audits.

The ideal candidate should have a BS/MS in Engineering or Life Sciences and 3+ years of relevant experience, along with strong technical writing and communication skills. DEKA is committed to driving quality excellence and fostering a collaborative work environment.