Senior Quality Systems Engineer

Senior Quality Systems Engineer

DEKA is hiring a Senior Quality Systems Engineer to own the system-level work that keeps our QMS audit-ready. As a Senior Quality Systems Engineer, you'll be working closely with the QA & Compliance Manager and partnering across Engineering, Operations, Regulatory, and Manufacturing to strengthen and mature the DEKA QMS.

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

• Develop and apply a deep working knowledge of DEKA's QMS to identify, propose, and implement system improvements to ensure ongoing compliance with FDA 21 CFR Part 820, FDA QMSR, and ISO 13485.
• Apply risk-based decision-making to:
• Ensure the quality system is fit for purpose, and drive QMS improvements and changes through to implementation.
• Partner with project teams to implement QMS requirements at the project level, providing practical solutions and alternative compliance paths that meet regulatory expectations without stalling project execution.
• Lead cross-functional CAPA review meetings, guiding teams through systemic issue identification and alignment on remediation strategies. In some cases, this role will also own CAPAs and drive root cause investigations.
• Monitor CAPA trends and performance metrics to identify recurring issues and drive continuous improvement across the QMS.
• Develop and revise system-level SOPs and associated change controls to align with regulatory requirements and maintain QMS compliance.
• Develop training, and mentor junior team members
• Review quality plans, documents, and records, ensuring accuracy, completeness, and adherence to applicable requirements.
• Plan and conduct audits (e.g., Internal, FDA, ISO, customer audits)
• Prepare inputs and supporting analysis for Management Review.

As a senior contributor to our team, you will demonstrate the following skills:

• Strong technical writing skills: you produce precise, audit-ready documentation and 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 and hold a position with engineering, operations, and leadership.
• Strong project ownership and follow-through and keep things moving without close oversight.
• A proactive problem-solver mindset: you ask the right questions, challenge assumptions, and help teams find workable solutions.
• Collaborative energy: you contribute, share ideas, and maintain a constructive, can-do attitude.
• Precision and attention to detail: your work is thorough, consistent, and traceable.
• Reliability: you take ownership, meet deadlines, and follow through.

Required Training / Knowledge:

• BS in Engineering, Life Sciences, or related field
• 5+ years in a quality systems role in a regulated industry, medical devices preferred
• Demonstrated experience authoring and/or updating system-level QMS procedures
• Prior experience leading internal audits and supporting external audits (FDA, notified body, customer)
• Prior experience owning, implementing, and verifying complex CAPAs
• Proficiency in FDA QMSR (21 CFR Part 820) regulations, and ISO 13485 and ISO 14971 standards
• Experience with eQMS platforms
• Proficiency with Microsoft Office and Visio

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 & 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.