Quality Systems Specialist

5 days ago


Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom Quantumdx Group Full time
Job Summary

We are looking for a Quality Systems Specialist to join our team at Quantumdx Group. The successful candidate will be responsible for ensuring products and design and development of future products are compliant with the requirements of ISO 13485 and ISO 14971 and IEC 62304.

Main Responsibilities:

  • Champion the highest level of quality & process and undertake training;
  • Work with purchasing staff to establish Quality requirements from external suppliers;
  • Help to compile and maintain Medical Device Files, Technical Files and Device Master Records and product risk management files;
  • QA review of both internal and contractor generated documentation;
  • Take an active role in the risk management process;
  • Support the administration of a company-wide risk-based comprehensive training system;
  • Design and deliver training sessions to ensure understanding and compliance of all employees.

Requirements:

The ideal candidate will have industry experience working within a Quality Management System, with some specific experience of working with IVD medical devices. They should also possess outstanding teamwork and ability to interact with external and internal partners on fast-paced projects.

Salary: £60,000 - £75,000 per annum

Location: UK



  • Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom & Security Systems Ltd Full time

        As a System Commissioning Specialist at & Security Systems Ltd, you will play a key role in ensuring the successful installation and commissioning of fire detection and alarm systems, life safety systems, and security systems. Your primary responsibility will be to install and/or commission these systems, provided you have received adequate training...


  • Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom & Security Systems Ltd Full time

    About the RoleWe are seeking a highly skilled Fire Detection and Alarm Systems Specialist to join our team at & Security Systems Ltd. As a key member of our operations team, you will be responsible for the installation, commissioning, and servicing of fire detection and alarm systems, life safety systems, and security systems.The ideal candidate will have a...


  • Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom beBee Professionals Full time £28,000 - £35,000

    Electrical Systems SpecialistbeBee Professionals is seeking a skilled Electrical Systems Specialist to join our team in Newcastle upon Tyne. As an Electrical Systems Specialist, you will be responsible for installing, maintaining, and repairing electrical systems in residential, commercial, and industrial settings, ensuring safety and compliance with...


  • Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom Golden Fox Recruitment Ltd Full time

    Job Title: Water Systems SpecialistLocation: Newcastle Upon Tyne, UKEstimated Salary: Up to £30,000 per annumAbout the RoleWe are seeking an experienced Water Systems Specialist to join our team.Key ResponsibilitiesThe successful candidate will conduct water sampling and temperature monitoring to ensure compliance with industry regulations.Perform cleaning...


  • Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom ArcelorMittal SA Full time

    Position SummaryArcelorMittal South Africa Limited seeks a skilled System Implementation Specialist to join our team in Newcastle. The successful candidate will have a market-related salary and a strong background in system implementation and maintenance.This role involves designing, developing, testing, and deploying high-quality solutions according to set...


  • Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom TS Tech Americas, Inc. Full time

    Job DescriptionWe are seeking a highly skilled and experienced Production Systems Specialist to join our team. The successful candidate will be responsible for managing and improving our production processes, ensuring that we meet our quality and efficiency targets.Key responsibilities include designing and implementing new production systems, identifying...


  • Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom Rise Technical Recruitment Limited Full time

    Electrical Systems SpecialistEstimated Salary: £40,000 - £50,000 + BenefitsThis role presents an exceptional opportunity for qualified Electricians or Electrical Engineers to transition into the medical industry. As a specialist in electrical systems, you will be exposed to cutting-edge, bespoke medical equipment and have the chance to become a fully...


  • Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom Siemens Energy Full time

    About the RoleAs a Quality Assurance Specialist, you will play a key part in ensuring that our Gas Services division meets the highest standards of quality and safety. You will work closely with the Head of Quality to develop and implement the Quality Management System, ensuring compliance with ISO 9001.You will also represent Siemens Energy on quality...


  • Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom WSP Full time

    Succeed as an Offshore Electrical Systems Specialist at WSP and take advantage of an attractive salary range of $110,000 - $140,000 per year. In this dynamic role, you will contribute to the success of our ENERGY business by developing and implementing innovative solutions for offshore electrical systems.About the PositionThis is a fantastic opportunity to...


  • Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom Jackson Hogg Ltd Full time

    Job Title: Electrical Signalling Systems SpecialistWe are seeking an experienced Electrical Signalling Systems Specialist to join our team at Jackson Hogg Ltd. This role involves the correlation testing, installation and modifications of signalling systems and equipment.Main Responsibilities:Liaising with other departments regarding testing and handing back...


  • Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom Nigel Wright Group Full time

    Our Client:Nigel Wright Group is pleased to be working with an international manufacturer of a highly regulated product to recruit a Quality Management System Coordinator who will join their team in the Newcastle area. The Role:The Quality Management System Coordinator role will include responsibilities such as:Leading and supporting various functions of the...


  • Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom Omega Resource Group Full time

    As an Electrical Systems Specialist at Omega Resource Group, you will be part of a global engineering team covering industries such as mobility, energy, and power conversion. Your expertise in automated substation equipment will be crucial in our Newcastle office.The ideal candidate will have experience working with electrical test equipment and a strong...


  • Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom Advance TRS Full time £36,000 - £64,000

    About the RoleAdvance TRS is seeking a highly skilled Electrical Systems Specialist to join their multidisciplinary design team. The successful candidate will be responsible for designing and developing electrical systems in one of their UK offices.Key ResponsibilitiesDesign and develop electrical systems for various projectsCollaborate with cross-functional...


  • Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom BFBi Midland Section Committee Full time

    Company Overview:BFBi Midland Section Committee is a leading provider of dispensing systems to the brewing, food, and beverage industry.About the Role:We are seeking an experienced Dispense System Specialist to join our team. As a key member of our technical support group, you will be responsible for installing, maintaining, and ensuring the optimal...


  • Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom westlakesrecruit Full time

    Job DescriptionWe are looking for an experienced Control Systems Specialist to join our team in Newcastle. As a Control Systems Specialist, you will work on the systematic design lifecycle of control and instrumentation (C&I) systems, including specification, design, assessment, verification, testing, installation, commissioning, and maintenance.You will...


  • Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom Newcastle University Full time

    We are seeking a highly skilled Data Quality Specialist to join our team at Newcastle University. As a key member of the NIHR Research Support Service (RSS), you will play a vital role in ensuring the accuracy, consistency, and quality of data collected and maintained by the RSS.About the RoleThis is a full-time fixed-term position available until 30...


  • Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom Ronald James Ltd. Full time

    About the RoleWe are looking for a highly skilled Quality Assurance Specialist to join our team in a fast-growing digital marketing agency.Responsibilities:Develop and execute test strategies to ensure high-quality software products.Collaborate with cross-functional teams to define project requirements and testing scope.Design and implement automated tests...


  • Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom Baker Hughes Gruppe Full time

    About the RoleWe are seeking a highly skilled Pipe Systems Specialist to join our Flexible Pipe Systems Offshore team based in Newcastle, UK.As part of this role, you will be responsible for assembling, installing, and maintaining mechanical systems and components according to specifications and engineering drawings. This requires a strong understanding of...


  • Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom Rise Technical Recruitment Full time

    Machining Systems Specialist Wanted by Rise Technical RecruitmentWe are currently recruiting for a talented Machining Systems Specialist to join our team at Rise Technical Recruitment. As a Machining Systems Specialist, you will be responsible for the installation and repair of CNC machinery, working closely with customers to provide excellent service.About...


  • Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom Northumbria Police Full time

    Job DescriptionWe are seeking an experienced Forensic Quality Assurance Specialist to join our team at Northumbria Police. As a key member of our Forensic Services Department, you will play a vital role in ensuring the highest standards of quality and integrity in our forensic processes.Key Responsibilities:Maintain and improve our Quality Management Systems...