3 дня назад
Quality Assurance Engineer (Medical Devices)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
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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