Senior Quality Assurance Specialist

1 month ago

Manchester, United Kingdom Yourgene Health Full time

Job title: Senior Quality Assurance Specialist

Reports to: Quality Assurance Manager

Location: Manchester Science Park (M15 6SH)

Contract Type: Full-time, Permanent

Salary & Benefits: Competitive Salary + Benefits Package


About Yourgene Health:

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


Yourgene primarily develops, manufactures, and commercialises simple and accurate molecular diagnostic solutions, for reproductive health, precision medicine and infectious diseases. The Group's flagship in vitro diagnostic products include non -invasive prenatal tests (NIPT) for Down's Syndrome and other genetic disorders, Cystic Fibrosis screening tests, invasive rapid aneuploidy tests and DPYD genotyping.


Yourgene has 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.


Yourgene also has 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. In addition, Yourgene offers and NIPT and high throughput Covid testing service.


Yourgene Health is headquartered in Manchester, UK with facilities in Taipei, Singapore, the US and Canada.


Our Culture:

Yourgene is a growing, vibrant and exciting place to work, we are looking for committed driven individuals to be part of our next growth journey. Our culture is described by our employee's as collegiate, friendly, professional, innovative, open and fast paced. We have nay social and well-being initiatives run by our Social Huddle that keep our sense of community alive during challenging times that the pandemic has thrown our way. At Yourgene we focus on putting values led programmes in place to ensure that we can attract, retain and develop our people. We want our people to have a career with Yourgene and we ensure that they are recognised and rewarded for their achievements and commitment, everyone plays a critical role in our growth journey.


Description of role:

Yourgene Health, part of Novacyt Group are recruiting for a Senior Quality Assurance (QA) Specialist. The Senior Quality Assurance Specialist will play a critical role in ensuring that our organization adheres to regulatory requirements, industry standards, and internal quality processes. Reporting to the Quality Assurance Manager, you will be responsible for overseeing quality management systems, ensuring compliance with internal process and external requirements, and supporting continuous improvement efforts across the organization.


Overall responsibility:

The role is a senior role within the QA department which requires some leadership of other QA members and decision making. The overall responsibility of the role is to ensure that our organization adheres to regulatory requirements, industry standards, and internal quality processes.


Key areas of responsibility:

  • Development, implementation, and maintenance of the company's Quality Management System in accordance with ISO13485 standards and regulatory requirements.
  • Conduct internal audits and assessments to ensure compliance with internal quality procedures and external regulatory standards.
  • Assist in the management of equipment used in QA processes, ensuring proper maintenance and availability.
  • Assist in completing activities and maintaining records within the QMS related to Nonconformities and Corrective Actions, ensuring timely resolution and documentation.
  • Perform product releases by reviewing and approving products or services, ensuring they meet established quality standards.
  • Collaborate with cross-functional teams to identify opportunities for process optimization and quality improvements
  • Support design and development activities
  • Support Post Market Surveillance Activities
  • Support IVDR Technical documentation activities


Qualifications, Skills and Abilities:

  • Degree level educated ideally in relevant discipline.
  • Previous experience of Quality Management Systems (ISO 13485)
  • Awareness of IVDR 2017/746 requirements
  • Previous experience of using electronic QMS Software, such as Q-Pulse
  • Attention to detail
  • Good organisational and planning skills
  • Good communication skills


Closing Date:

Sunday 25th August, 2024


Yourgene Health is committed to encouraging equality, diversity and inclusion among our workforce. The aim is 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.

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