Software Quality Assurance Engineer

DEKA Research & Development
Manchester
Workplace: OnsiteFull timeFunction: QA, Test & Release EngineeringExperience: 5-8 yearsEducation: bachelorsSkills: ["Communication","Cross-functional coordination","Independent work","Process-driven thinking","Regulatory-to-engineering translation"]

Own and standardize software lifecycle documentation and quality processes for a cloud-native engineering team. Embed with engineers to codify documentation best practices, drive documentation change control, and maintain audit-ready traceability across requirements, design, risks, tests, and defects. Lead readiness reviews ahead of design freeze and regulatory milestones while championing automation-first, DevSecOps-oriented quality practices to help developers focus on product code.

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DEKA Research & Development
DEKA Research & Development
1 month ago

Software Quality Assurance Engineer

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Source: Company careers pageValidated by: Fursa AI
Last checked: 20 hours agoStatus: Live

Job Summary

Own and standardize software lifecycle documentation and quality processes for a cloud-native engineering team. Embed with engineers to codify documentation best practices, drive documentation change control, and maintain audit-ready traceability across requirements, design, risks, tests, and defects. Lead readiness reviews ahead of design freeze and regulatory milestones while championing automation-first, DevSecOps-oriented quality practices to help developers focus on product code.
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 documentation and automation practices, then produce standardized templates, work instructions, and SOPs for consistent use across cloud-native product lines.
  • •Own and author software lifecycle documentation artifacts (SDPs, SRS, SDD, V&V plans/reports, and software risk management files).
  • •Drive document change control and coordinate review cycles to keep releases on schedule, escalating blockers early to drive resolution.
  • •Establish and maintain traceability matrices linking requirements, design elements, risk controls, test cases, and defects for audit-ready evidence.
  • •Manage documentation project plans for each release and facilitate readiness reviews ahead of design freeze, test execution, and regulatory submission 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 closely adjacent technical roles, with at least 2 years in an FDA-regulated environment.
  • •Hands-on 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, including contributing to FMEAs and software hazard analyses.
Experience:5-8 yearsFDA-regulatedMedical devicesDigital healthCloud-nativeDevSecOps
Education:Bachelor's in Computer Science, Software Engineering, or a closely related technical discipline
Skills:CommunicationCross-functional coordinationIndependent workProcess-driven thinkingRegulatory-to-engineering translation
Certifications:ASQ CSQEISTQBRAC
Tech Stack:GoJavaPythonTerraformAnsiblePlaywrightPytestNISTMicroserviceIAM

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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