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
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.
