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. Responsibilities 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. 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. Requirements 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. #J-18808-Ljbffr DEKA Research & Development