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Quality Engineer Medical Devices

Job LocationCambridge
EducationNot Mentioned
Salary£40,000 - £45,000 per annum
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent, full-time

Job Description

Quality Engineer - Medical Devices Regulatory StandardsWe are looking for a Quality Assurance Engineer with strong regulatory experience in the medical technology field. Your background in medical devices quality standards will be key for this Cambridge-based position.You will be responsible for managing the Quality Management System (QMS) within ISO 13485 standards, so experience working under the Medical Devices Directive (MDD) and Regulation (MDR) is vital. You will also be in charge of regulatory obligations of the full product lifecycle.Other Key Skills/Experience:

  • Extensive QA knowledge of the Medical Device Industry
  • US FDA 21 CFR 820 Quality Systems Regulation
  • Medical Device EU CE marking process and MDD/MDR
  • US FDA product approval process e.g. 510k
  • ISO 14971, IEC 60601, IEC 62304 and sterile devices standards
  • Understand Class I, II and Class III medical devices
  • Experience with sterile single-use devices including process validation
  • Experience working with external contract design and manufacturing organisations
  • A Science or Engineering degree
  • You will lead regulatory features within the product development process, as well as plan and conduct internal audits. The Quality Engineer will liaise with international regulatory authorities concerning the QMS and product certificationThe position is based in Cambridge with a well-funded medical devices company that already has new exciting MedTech products in the pipeline. Salary to £45k. Required skills
  • Medical Devices
  • Quality Assurance
  • Quality Management
  • Regulatory Standards
  • Medtech
  • Keyskills :
    Medical Devices Quality Assurance Quality Management Regulaty Standards Medtech

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