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.