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3 дня назад

Quality Assurance Engineer (Medical Devices)

Формат работы
hybrid
Тип работы
fulltime
Английский
b2
Страна
UK
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

Текст:
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TL;DR
Quality Assurance Engineer (Medical Devices): Maintaining and improving the quality management system for regulated medical-device and cancer-care technology with an accent on compliance, audits, CAPA, and patient safety. Focus on investigating non-conformances, performing root cause analysis, translating regulatory requirements into practical processes, and driving cross-functional quality improvements.

Location: Crawley HQ, United Kingdom; 4 days onsite and 1 day working from home

Company

Develops precision radiation therapy and radiosurgery technology designed to improve access to cancer care.

What you will do

  • Maintain and continuously improve the Quality Management System.
  • Lead quality and compliance activities across procurement, supply chain, manufacturing, regulatory affairs, and logistics.
  • Monitor quality metrics, analyse trends, and identify continuous improvement opportunities.
  • Plan and support internal audits, external audits, and regulatory inspections.
  • Investigate non-conformances, perform root cause analysis, and implement and close CAPA actions.
  • Review quality documentation and support process improvements and regulatory compliance.

Requirements

  • Degree in engineering, a related discipline, or equivalent industry experience, including a formal engineering apprenticeship.
  • Experience in a quality, regulatory, or engineering role within a regulated industry, ideally medical devices.
  • Knowledge of ISO 13485, MDR, IEC, QSR, and MDSAP standards.
  • Experience with CAPA, root cause analysis, Lean, Six Sigma, or similar quality improvement methods.
  • Strong problem-solving, communication, stakeholder management, and collaboration skills.
  • Ability to interpret regulatory requirements and translate them into practical business solutions.

Nice to have

  • Professional quality certification such as CQI, CQE, or CQA.
  • Certified auditor training.

Culture & Benefits

  • Work focused on improving access to cancer care and patient outcomes.
  • Up to 25 paid vacation days plus bank holidays.
  • Holiday purchase scheme and private medical insurance.
  • Employer pension contribution package and life assurance.
  • Cycle-to-work scheme and electric vehicle salary sacrifice scheme.
  • Onsite subsidized restaurant.

Hiring process

  • Submit an application and résumé in English through the application system.

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