Software Quality Assurance Engineer

DEKA Research & Development
Manchester
Workplace: OnsiteFull timeFunction: QA, Test & Release EngineeringExperience: 5-8 yearsEducation: bachelorsSkills: ["Automation-first mindset","Documentation quality focus","Clear communication","Cross-functional coordination","Independent prioritization"]

Join the cloud engineering team as an individual contributor who embeds with engineers to standardize software lifecycle documentation and automation-driven quality practices. You’ll author and maintain audit-ready artifacts (SDPs, SRS, SDD, V&V plans/reports, risk management files), run document change control and traceability matrices, and ensure readiness for design freeze, testing, and regulatory milestones. Bring hands-on ability to read code and automated tests in Go, Java, Python, and modern IaC tooling.

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DEKA Research & Development
DEKA Research & Development
1 day ago

Software Quality Assurance Engineer

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Last checked: 2 hours agoStatus: Live
Reposted: similar role first listed 2 months ago

Job Summary

Join the cloud engineering team as an individual contributor who embeds with engineers to standardize software lifecycle documentation and automation-driven quality practices. You’ll author and maintain audit-ready artifacts (SDPs, SRS, SDD, V&V plans/reports, risk management files), run document change control and traceability matrices, and ensure readiness for design freeze, testing, and regulatory milestones. Bring hands-on ability to read code and automated tests in Go, Java, Python, and modern IaC tooling.
Location: Manchester
Workplace: Onsite
Employment Type: Full time
Job Function: QA, Test & Release Engineering
Seniority: Mid level

Key Responsibilities

  • •Embed with engineering teams to understand existing documentation practices and automation tools, then produce standardized templates, work instructions, and SOPs.
  • •Serve as the primary author and owner for software lifecycle documentation artifacts including SDPs, SRS, SDD, V&V plans/reports, and Software Risk Management Files.
  • •Drive document change control from initiation through approval and coordinate review cycles to keep releases on schedule.
  • •Establish and maintain traceability matrices linking requirements, design elements, risk controls, test cases, and defects for audit-ready evidence.
  • •Own the documentation project plan for each software release, track documentation tasks and approval gates, and facilitate readiness reviews before key milestones.

Key Requirements

  • •Bachelor’s degree in Computer Science, Software Engineering, or a closely related technical discipline.
  • •5–8 years of combined experience in software quality engineering or software development, with at least 2 years in an FDA-regulated environment.
  • •Ability to read and reason about Go, Java, or Python code, Infrastructure-as-Code (Terraform, Ansible), and automated test code (Playwright, pytest).
  • •Experience producing IEC 62304-compliant documentation for Class B or Class C software.
  • •Practical knowledge of ISO 14971 risk management for medical device software, including FMEAs and software hazard analyses.
Experience:5-8 yearsFDA-regulated environmentMedical devicesDigital healthPharmaceutical softwareCloud-native architectures
Education:Bachelor's in Computer Science, Software Engineering, or a closely related technical discipline
Skills:Automation-first mindsetDocumentation quality focusClear communicationCross-functional coordinationIndependent prioritization
Certifications:ASQ CSQEISTQBRAC
Tech Stack:GoJavaPythonTerraformAnsiblePlaywrightPytestIEC 62304ISO 14971NISTFDA cybersecurityMicroservice architecturesEvent-driven architecturesIAMFMEAsSoftware hazard analyses

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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