FDA 21 CFR

Part 820 and ISO 13485, maintaining the integrity and effectiveness of the

DEKA QMS.

Develop a strong working knowledge of DEKA's QMS processes and use this expertise to identify and implement system improvements. Review and approve quality records, ensuring accuracy, completeness, and adherence to applicable requirements. Conduct internal audits and support auditor training efforts to promote audit readiness and compliance with regulatory requirements. Support external audits (e.g., FDA, ISO, customer audits) by preparing documentation, facilitating audit logistics, and responding to auditor requests in real time. As a key contributor to our team, you will demonstrate the following skills: 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. Required Training /

Knowledge:

BS/MS in Engineering, Life Sciences, or a related field 3+ years of experience in a quality systems role in a regulated industry, ideally medical devices 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 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. 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Quality Systems Engineer CAPA and Process Improvement