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12 дней назад

Senior Software Quality Engineer (Medical Devices)

76 800 - 115 200GBP
Формат работы
hybrid
Тип работы
fulltime
Грейд
senior
Английский
b2
Страна
UK
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

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TL;DR
Senior Software Quality Engineer (Medical Devices): Supporting software quality across the medical device product lifecycle with an accent on design controls, risk management, verification and validation, and regulatory compliance. Focus on reviewing requirements and test evidence, investigating defects, supporting audits and CAPA activities, and improving software quality for safe and reliable products.

Location: London, United Kingdom; minimum 3–4 days onsite per week

Salary: £76,800–£115,200 per year, plus eligibility for the hirify.global Incentive Plan.

Company

hirify.global develops healthcare technologies, services, and solutions used to improve patient health and extend lives worldwide.

What you will do

  • Support software quality activities from requirements and design through verification, validation, release, and post-market support.
  • Review software requirements, architecture, algorithms, technical designs, test evidence, and traceability documentation.
  • Support software risk management, including SFMEA, hazard analysis, risk mitigation, and verification.
  • Contribute to verification and validation planning, defect investigations, root cause analysis, CAPA, and release readiness.
  • Collaborate with software, systems, regulatory, and quality teams on compliance, audits, documentation, and process improvement.
  • Provide quality input on reliability, cybersecurity, usability, configuration management, and change control.

Requirements

  • Bachelor’s degree in engineering, computer science, software engineering, science, or a related technical field.
  • 3–7 years of experience in software quality, software development, verification and validation, or a related engineering or quality role.
  • Working knowledge of software development lifecycle activities, design controls, requirements traceability, verification and validation, and risk management.
  • Strong analytical, documentation, problem-solving, communication, and prioritization skills.
  • Ability to collaborate across functions and organizational levels and deliver work on time.

Nice to have

  • Experience in medical device or other regulated product development environments.
  • Familiarity with ISO 13485, ISO 14971, IEC 62304, 21 CFR 820, and IEC 60601-1.
  • Knowledge of Agile development and experience with embedded software, mobile applications, or medical device software.
  • Experience with cybersecurity evaluations, audits, inspections, or regulatory submissions.

Culture & Benefits

  • Hybrid work arrangement with regular in-person collaboration.
  • Competitive salary and flexible benefits package.
  • Short-term incentive eligibility through the hirify.global Incentive Plan.
  • Work focused on healthcare innovation, patient safety, professional growth, and cross-functional collaboration.

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