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Quality Assurance Specialist

2 months ago

Manchester, United Kingdom Yourgene Health Full time
Job Description

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.

Job Summary

We are seeking a highly skilled Quality Assurance Specialist to join our team. The successful candidate will be responsible for ensuring the maintenance and continuous improvement of our Quality Management Systems (QMS).

Key Responsibilities

  • Product Release Management

Review and approve products or services to ensure they meet established quality standards.

QMS Development and Implementation

Collaborate in the development, implementation, and enhancement of QMS documents and processes to ensure compliance with quality standards.

Nonconformity and Corrective Action Management

Assist in completing activities and maintaining records within the QMS related to Nonconformities and Corrective Actions, ensuring timely resolution and documentation.

Supplier Management

Support the supplier management process by evaluating suppliers, conducting audits, and ensuring adherence to quality requirements.

Equipment Management

Assist in the management of equipment used in QA processes, ensuring proper maintenance and availability.

Internal Audits

Conduct internal audits as required to assess compliance with the QMS, identify areas for improvement, and implement corrective actions.

Training and Support

Provide training and support to users of the QMS, ensuring understanding and adherence to established procedures.

Reporting and Metrics

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