- Perform product releases by reviewing and approving products or services, ensuring 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.
- HND/Graduate level or previous experience in Quality Assurance role
- Understanding of ISO13485, ISO15189 or ISO9001 requirements
- Previous experience working with In Vitro Devices (IVD/IVDR) or Medical Devices (MDD/MDR)
- Attention to detail/concern for impact
- Good organisational and planning skills
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Quality Assurance Specialist - manchester, United Kingdom - Yourgene Health
Description
Job DescriptionJob title: Quality Assurance Specialist
Reports to: Quality Assurance Manager
Location: Manchester Science Park
Contract Type: Permanent / Full-Time
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. Yourgene work 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 and precision medicine. Yourgene'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 Size Selection instruments, powered by Ranger Technology, ideal for cell-free DNA applications in NIPT, oncology including liquid biopsy, long fragment recovery and gene synthesis applications.
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 an NIPT testing service in the Manchester laboratory.
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 plenty of social and well-being initiatives run by our Nova Social & Charity Huddle that keep our sense of community alive and allow us to be part of charity fundraisers. 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.
About the role:
We are looking to recruit a full-time and permanent QA Specialist to work within the quality assurance team based in Manchester. The QA Specialist will ensure the maintenance and continuous improvement of the company quality management system (Q-Pulse).
Key areas of responsibility:
Qualifications, Skills and Abilities
Essential:
Closing Date:
Sunday 2nd June, 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.
