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...