Quality Systems Engineer - CAPA and Process Improvement

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 our dynamic team at DEKA and be at the forefront of driving quality excellence! As our Quality Systems Engineer, you'll be a key player in our collaborative environment, working hand-in-hand with cross-functional teams to ensure the highest standards of quality and compliance.

Responsibilities

• Own and manage the end-to-end CAPA process, from intake and triage through investigation, root cause analysis, corrective/preventive action planning, and effectiveness verification.
• Facilitate cross-functional CAPA review meetings, ensuring teams identify systemic issues and align on appropriate remediation strategies.
• Ensure each CAPA is supported with objective evidence, clear problem statements, and traceability to impacted processes, products, or quality records.
• Maintain CAPA documentation in alignment with regulatory expectations, ensuring timely closure, audit readiness, and linkage to risk management where applicable.
• Monitor CAPA trends and performance metrics to identify recurring issues and drive continuous improvement.
• Support training and mentorship of team members on CAPA expectations, best practices, and root cause analysis tools.
• Own the development and revision of Standard Operating Procedures (SOPs) and associated change controls to ensure they align with regulatory requirements and support QMS compliance.
• Ensure ongoing compliance with FDA 21 CFR Part 820 and ISO 13485, maintaining the integrity and effectiveness of the DEKA QMS.
• Develop a strong working knowledge of DEKA's QMS processes and use this expertise to identify and implement system improvements.
• Review and approve quality records, ensuring accuracy, completeness, and adherence to applicable requirements.
• Conduct internal audits and support auditor training efforts to promote audit readiness and compliance with regulatory requirements.
• Support external audits (e.g., FDA, ISO, customer audits) by preparing documentation, facilitating audit logistics, and responding to auditor requests in real time.

Skills

• Strong technical writing skills: you can translate complex concepts clearly for diverse audiences.
• A natural curiosity and ability to quickly grasp technical systems, workflows, and requirements.
• Clear, confident communication: you know how to explain problems and solutions across a range of technical backgrounds.
• Solid project coordination and follow-through: you're organized, dependable, and keep work moving forward.
• A proactive problem-solver mindset: you ask the right questions, challenge assumptions, and help teams find solutions.
• Collaborative energy: you contribute, share ideas, and maintain a constructive, can-do attitude.
• Precision and attention to detail: your work is thorough and consistent.
• Reliability: you take ownership, meet deadlines, and follow through.

Requirements

• 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