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Quality Assurance Specialist

2 months ago

Manchester, United Kingdom Yourgene Health Full time
About the Role

We are seeking a highly skilled Quality Assurance Specialist to join our team at Yourgene Health. As a Quality Assurance Specialist, you will play a critical role in ensuring the maintenance and continuous improvement of our Quality Management Systems (QMS).

Key Responsibilities
  • Perform product releases by reviewing and approving products or services to ensure they meet established quality standards.
  • Collaborate in the development, implementation, and enhancement of QMS documents and processes to ensure compliance with quality standards.
  • Assist in completing activities and maintaining records within the QMS related to Nonconformities and Corrective Actions, ensuring timely resolution and documentation.
  • Support the supplier management process by evaluating suppliers, conducting audits, and ensuring adherence to quality requirements.
  • Assist in the management of equipment used in QA processes, ensuring proper maintenance and availability.
  • Conduct internal audits as required to assess compliance with the QMS, identify areas for improvement, and implement corrective actions.
  • Provide training and support to users of the QMS, ensuring understanding and adherence to established procedures.
  • Generate reports and metrics on current QA activities, evaluate the effectiveness of the QMS, and identify areas for improvement, contributing to continuous improvement initiatives.
Requirements
  • HND/Graduate level or previous experience in Quality Assurance role.
  • Understanding of ISO13485.
  • Previous experience working in In Vitro Devices or Medical Devices.
  • Attention to detail/concern for impact.
  • Good organisational and planning skills.
  • Good communication skills.
About Yourgene Health

Yourgene Health is a leading integrated technologies and services business, enabling the delivery of genomic medicine. We work in partnership with global leaders in DNA technology to advance diagnostic science.

We primarily develop, manufacture, and commercialise simple and accurate molecular diagnostic solutions, for reproductive health, precision medicine, and infectious diseases.

We have a range of innovative DNA sample preparation platforms, powered by Ranger Technology, the Yourgene LightBench and Yourgene QS250, ideal for cell free DNA applications in NIPT and oncology including liquid biopsy.

We also have a global laboratory service network equipped to be a full life-cycle partner for clinical, research, and pharmaceutical organisations to support partners at the preclinical, clinical, and post market stage to develop, manufacture, obtain regulatory approval, and commercialise new products and services.

We are committed to encouraging equality, diversity, and inclusion among our workforce. We aim for our workforce to be truly representative of all sections of society and for each employee to feel respected and able to give their best.