Senior Quality Systems Engineer

• Develop and apply a deep working knowledge of DEKAs 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 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.

• 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.

• 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 DEKAs 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.