Quality Systems Engineer – CAPA and Process Improvement

DEKA Research & Development
Manchester
Workplace: OnsiteFull timeFunction: IT Operations (Systems/Network Admin)Experience: 3+ yearsEducation: bachelorsSkills: ["Strong technical writing","Clear communication","Project coordination","Proactive problem-solving","Attention to detail"]

Own the end-to-end CAPA process—from intake and triage through investigation, root cause analysis, corrective/preventive actions, and effectiveness verification. Lead cross-functional CAPA review meetings, maintain complete CAPA documentation for audit readiness, and monitor trends to drive continuous improvement. Develop and update SOPs and change controls, ensure QMS compliance with FDA 21 CFR Part 820 and ISO 13485, support internal/external audits, and train teams on CAPA expectations and problem-solving tools.

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DEKA Research & Development
DEKA Research & Development
4 days ago

Quality Systems Engineer – CAPA and Process Improvement

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Source: Company careers pageValidated by: Fursa AI
Last checked: 2 hours agoStatus: Live
Reposted: similar role first listed 1 month ago

Job Summary

Own the end-to-end CAPA process—from intake and triage through investigation, root cause analysis, corrective/preventive actions, and effectiveness verification. Lead cross-functional CAPA review meetings, maintain complete CAPA documentation for audit readiness, and monitor trends to drive continuous improvement. Develop and update SOPs and change controls, ensure QMS compliance with FDA 21 CFR Part 820 and ISO 13485, support internal/external audits, and train teams on CAPA expectations and problem-solving tools.
Location: Manchester
Workplace: Onsite
Employment Type: Full time
Job Function: IT Operations (Systems/Network Admin)
Seniority: Mid level

Key Responsibilities

  • •Own and manage the end-to-end CAPA process, including investigation, root cause analysis, corrective/preventive action planning, and effectiveness verification.
  • •Facilitate cross-functional CAPA review meetings and ensure systemic issues are identified with aligned remediation strategies.
  • •Maintain CAPA documentation for regulatory expectations, timely closure, audit readiness, and traceability to impacted processes/products/records.
  • •Develop and revise SOPs and associated change controls to support QMS compliance and regulatory alignment.
  • •Support internal and external audits by preparing documentation, facilitating auditor-related needs, and responding to audit requests.

Key Requirements

  • •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, including technical writing and project coordination.
Experience:3+ yearsRegulated industryMedical devices
Education:Bachelor's
Skills:Strong technical writingClear communicationProject coordinationProactive problem-solvingAttention to detail
Tech Stack:FDA QSR (21 CFR Part 820)ISO 13485Microsoft ExcelMicrosoft WordVisioCAPASOPsQMSRoot cause analysisFDAISO

Company Brief

DEKA Research & Development
DEKA Research & Development is a private R&D and product development firm founded by Dean Kamen that designs and manufactures medical devices, mobility systems, energy and water solutions, and low-volume production prototypes for healthcare and industrial customers.
Industry: Medical Devices
Company Size: Large (251 to 1,000 employees)
Growth: Established Company
Headquarters: Manchester, United States
Founded: 1982
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