Quality Systems Engineer – CAPA and Process Improvement

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

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.

As a Quality Systems Engineer, you will contribute in the following areas:

• 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.

As a key contributor to our team, you will demonstrate the following 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.

Required Training / Knowledge:

• 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

About DEKA:

One hour from the beach, Boston, and the mountains, the historic Amoskeag Millyard once housed the largest textile mills in the world. It is now home to DEKA Research and Development, where we are taking the same innovation and cutting-edge technology into the modern age.

Behind DEKA’s brick walls sits a team of professionals who strive to make a difference every day through thoughtful engineering, design, and manufacturing. Here at DEKA, some of the most innovative and life-changing products of our time are created, and new ideas are always welcome and explored.