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.
Key responsibilities as aQuality Systems Engineer:
- Own and manage the full CAPA process-from intake and investigation through corrective actions and effectiveness checks.
- Lead cross-functional CAPA meetings to identify systemic issues and align on remediation.
- Ensure CAPAs include objective evidence, clear problem statements, and traceability to impacted areas.
- Maintain timely, audit-ready CAPA documentation aligned with regulatory requirements and risk management.
- Track CAPA trends and metrics to identify recurring issues and drive improvements.
- Train and mentor team members on CAPA best practices and root cause analysis tools.
- Own the development and revision of SOPs and change controls to meet regulatory standards and support QMS compliance.
- Ensure ongoing compliance with FDA 21 CFR Part 820 and ISO 13485 to maintain QMS integrity.
- Build expertise in DEKA's QMS to identify and implement system improvements.
- Review and approve quality records for accuracy and compliance.
- Conduct internal audits and support auditor training.
- Support external audits by managing documentation, logistics, and real-time responses
What You Will Bring to the Team as aQuality Systems Engineer:
- 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.
To be successful in this role,the following skills and experience are required:
- BS/MS in Engineering, Life Sciences, or a related field
- 3+ years of experience in a quality systems role in a regulated industry, ideally in Medical Device
- 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 with exceptional attention to detail
- 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.
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DEKA Research and Development
Jun 07, 2025