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DEKA

31 Deka Jobs Hiring Near You

DEKA

Senior Quality Systems Engineer

Manchester, NH · On-site

$88.10K - $119.50K/yr

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 ...

DEKA

PCB Layout Designer

Manchester, NH · On-site

DEKA Research & Development is seeking a skilled PCB Layout Designer to join our engineering team. The successful candidate will be responsible for translating electrical schematics into optimized ...

DEKA

Director of Post Market Products

Manchester, NH · On-site

DEKA Research and Development, located in Manchester, NH, is a dynamic, growing company, focused on the development of new technologies that span a diverse set of applications. At DEKA we are ...

DEKA

Machinist - Entry Level

Manchester, NH · On-site

$21.75 - $29.50/hr

DEKA Research and Development, housed in Manchester, NH, is looking for a entry level machinist to work in our innovative machine shop. The Entry Level Machinist is a self-driven worker who has great ...

DEKA

Senior Test Engineer

Manchester, NH · On-site

DEKA Research & Development, located in Manchester, NH, is seeking a Senior Test Engineer to work in a dynamic medical device R&D environment. This is a high visibility role with a direct impact on ...

DEKA

Quality Engineer

Manchester, NH · On-site

$71.70K - $92.60K/yr

DEKA R&D has an immediate opening for a Quality Engineer to work in the Quality Department in a dynamic Medical Device Research and Development environment. The position reports to the Quality ...

DEKA

Senior Software Quality Engineer

Manchester, NH · On-site

DEKA Research and Development, housed in Manchester, NH, is looking for a dynamic, results driven and inventive Senior Software Quality Assurance Engineer to support the development of life-changing ...

DEKA

Product Complaints Engineer

Manchester, NH · On-site

DEKA R&D has an immediate opening for a Product Complaints Engineer to work in a dynamic Medical Device Research and Development environment. The position reports to the Product Complaints Manager.

DEKA

Electromechanical Technician

Manchester, NH · On-site

$24.75 - $31.25/hr

DEKA is looking for a hands-on, detail-oriented Engineering Service Technician to help keep our medical devices and test equipment running smoothly. In this role, you'll work with different groups ...

DEKA

Regulatory Affairs Project Manager

Manchester, NH · On-site

DEKA Research & Development has an immediate opening for a Regulatory Affairs Project Manager to contribute to a dynamic, medical device research and development environment. The individual in this ...

DEKA

CAD Designer

Manchester, NH · On-site

$27 - $37/hr

As a CAD Designer at DEKA Research & Development Corp., you will partner with both Mechanical and Electrical Engineering teams to support the full spectrum of CAD Department activities. In this role ...

DEKA

Senior Electrical Engineer

Manchester, NH · On-site

$107K - $139.40K/yr

Understand and follow DEKA processes, design control practices, and documentation requirements * Manage external design partners and suppliers * Manage your time effectively across multiple ...

DEKA

Mechanical Engineer

Manchester, NH · On-site

DEKA Research and Development, housed in Manchester, NH, is looking for an experienced mechanical design engineer to participate in the development of innovative medical devices. They will work as ...

DEKA

Lead Embedded Software Engineer

Manchester, NH · On-site

DEKA Research & Development is seeking a Lead Embedded Software Engineer to join our team working on cutting-edge medical devices. This role is a hands-on technical leadership position. You will lead ...

DEKA

Machinist/Toolmaker

Manchester, NH · On-site

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.

DEKA

Senior Manufacturing Engineer

Manchester, NH · On-site

$90.60K - $124K/yr

As a Senior Manufacturing Engineer at DEKA, you'll play a critical role in transforming innovative medical device designs into scalable, high-quality, and regulatory-compliant manufacturing solutions.

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Senior Quality Systems Engineer

DEKA

Manchester, NH • On-site

$88.10K - $119.50K/yr

Full-time

Posted 18 days ago

Job description

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.

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