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QMS and Operations Assistant

Job LocationLondon
EducationNot Mentioned
Salary£26,000 - £30,000 per annum
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent, full-time

Job Description

The RoleAs a QMS and Operations Assistant, you will assist in the day-to-day maintenance and monitoring of the quality management system against ISO 13485 and support the technical team in completing regulatory documentation for the release of Medical Devices onto the market.You will provide customer support and perform installations of medical devices in hospitals around the UK. You will work alongside our team of software engineers and talented team of researchers to support in the design and development of regulated medical devices.This role is ideal for someone who is eager to learn new skills and work in the exciting AI and Machine learning Medical Device industry.The role is initially home-based and will require the successful applicant to travel to customer sites/hospitals to install equipment and provide training.This role can be flexible with work hours around client needs.A clean UK drivers licence and access to your own vehicle is a must.Responsibilities/Tasks

  • Supporting the monitoring and maintenance of the Quality Management System under ISO 13485
  • Implementation of the company’s quality procedures, standards and specifications
  • Working with software engineers to establish standards, systems and procedures
  • Installation of medical devices in endoscopy suites in UK hospitals
  • Pro-actively seeking customer feedback and other post-market surveillance activities
  • Helping with the management of customers and monitoring feedback
  • Taking part in internal and external audits
  • Providing internal and external training
  • Acting as a catalyst for change and improvement in performance and quality
  • Work with purchasing staff to establish quality requirements from external suppliers
  • Reporting directly to the Quality and Operations Manager
  • Requirements
  • A full clean UK driving license and use of a car
  • Experience working with a Quality Management System created in-line with any ISO standard is desirable but not essential
  • This is an entry level job, training will be provided on ISO13485 and regulatory compliance if necessary
  • SkillsYoull need to have:
  • Communication and social skills
  • Analytical and problem-solving ability
  • Persistence and the ability to influence others
  • The ability to facilitate change
  • Attention to detail
  • An understanding and appreciation of other peoples work disciplines, such as software engineering and medical device manufacturing
  • About Us1 in 2 people will be diagnosed with cancer in their lifetime. Today, Colorectal Cancer (CRC) is the second most common cause of cancer related deaths in the UK. However, if it is diagnosed early, the treatment is simple and effective, with high survival rates. Odin Vision’s mission is to improve early detection and diagnosis of cancer in gastroenterology through artificial intelligence.Our award-winning technology has been developed in collaboration with scientific experts at University College London and with world renowned clinical opinion leaders at University College London Hospital. We believe Odin Vision’s technology is set to revolutionize clinical practice and we are looking for passionate people to join our team.

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