Quality Systems Engineer – CAPA and Process Improvement

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.

About deka

• 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.

Responsibilities

• 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.
• 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.

Requirements

• A natural curiosity and ability to quickly grasp technical systems, workflows, and requirements.
• you know how to explain problems and solutions across a range of technical backgrounds.
• you’re organized, dependable, and keep work moving forward.
• you ask the right questions, challenge assumptions, and help teams find solutions.
• you contribute, share ideas, and maintain a constructive, can-do attitude.
• your work is thorough and consistent.
• you take ownership, meet deadlines, and follow through.
• 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
• One hour from the beach, Boston, and the mountains, the historic