DEKA Research and Development Corporation

Quality Systems Engineer - CAPA and Process Improvement

DEKA Research and Development Corporation • $80K — $100K *
Manchester, NH 03103In-Person
Pharmaceuticals & Biotech
Less than 5 years of experience
Today
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Job Overview by Ladders

Qualifications

  • BS/MS in Engineering, Life Sciences, or related field
  • 3+ years in a quality systems role, preferably in medical devices
  • Familiarity with FDA QSR (21 CFR Part 820) and ISO 13485
  • Proficiency in Microsoft Excel, Word, and Visio
  • Strong verbal and written communication skills
  • Experience in project coordination and technical writing

Responsibilities

  • Manage the entire CAPA process from intake to closure
  • Facilitate cross-functional CAPA meetings for team alignment
  • Ensure CAPAs are backed by evidence and clear problem statements
  • Maintain CAPA documentation to meet regulatory standards
  • Monitor CAPA trends for continuous improvement
  • Mentor team members on CAPA processes and best practices
  • Develop and revise SOPs to support compliance with regulations

Benefits

  • Opportunity to contribute to quality systems in a regulated industry
  • Collaborative work environment with cross-functional teams
  • Mentorship opportunities to enhance professional growth
  • Engagement in continuous improvement initiatives
  • Hands-on experience with FDA and ISO audit processes
Full Job Description
As a Quality Systems Engineer, you will contribute in the following areas:
  • Own and manage the end-to-end CAPA process, from intake and triage through investigation, root cause analysis, corrective/preventive action planning, and effectiveness verification.
  • Facilitate cross-functional CAPA review meetings, ensuring teams identify systemic issues and align on appropriate remediation strategies.
  • Ensure each CAPA is supported with objective evidence, clear problem statements, and traceability to impacted processes, products, or quality records.
  • Maintain CAPA documentation in alignment with regulatory expectations, ensuring timely closure, audit readiness, and linkage to risk management where applicable.
  • Monitor CAPA trends and performance metrics to identify recurring issues and drive continuous improvement.
  • Support training and mentorship of team members on CAPA expectations, best practices, and root cause analysis tools.
  • Own the development and revision of Standard Operating Procedures (SOPs) and associated change controls to ensure they align with regulatory requirements and support QMS compliance.
  • Ensure ongoing compliance with 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 Research and Development Corporation

DEKA Research and Development Corporation is a research and development company based in Manchester, New Hampshire. The company was founded in 1982 by Dean Kamen, an inventor and entrepreneur who has over 440 patents to his name. DEKA is known for developing innovative technologies in a variety of fields, including medical devices, robotics, and transportation. Some of the company's most notable inventions include the Segway personal transporter, the iBOT mobility system, and the DEKA Arm prosthetic limb. DEKA has received numerous awards and accolades for its work, including the National Medal of Technology and Innovation in 2000.
Learn more about DEKA Research and Development Corporation
Size
1,000 employees
Industry
Aerospace & Defense
Founded
1982
* Ladders Estimates

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