Quality Assurance Specialist

7 days ago

Witney, Oxfordshire, United Kingdom Abbott Full time
About the Role

We are seeking a highly skilled Quality Assurance Specialist to join our team at Abbott Diabetes Care. As a key member of our Quality Team, you will play a critical role in ensuring the quality and compliance of our products.

Key Responsibilities
  • Support the CAPA process for the Witney Site, ensuring timely and effective resolution of quality issues.
  • Project manage Non-conformances, Potential non-conformances, and Deviations within agreed timelines, ensuring compliance with regulatory requirements.
  • Coordinate cross-functional team activities to investigate and resolve quality issues, identifying root causes and implementing corrective actions.
  • Project manage CA/PA / Corrections / Effectiveness Checks within the CAPA system, ensuring timely and effective resolution of quality issues.
  • Support the tracking and trending of CAPA metrics, providing insights to inform quality improvement initiatives.
  • Investigate, document, and remediate quality issues, communicating and escalating as required to ensure compliance with regulatory requirements.
  • Deliver the quality message across the site through team training, presentations, and tool box talks, promoting a culture of quality and compliance.
  • Support the monitoring and compliance of the Quality Management System as it applies to site Operations, ensuring adherence to regulatory requirements.
  • Plan, conduct, and review inspections for all areas as per the inspection plan, communicating findings and working with area leads to implement corrective actions.
  • Support Operations to make quality/compliance decisions on product during processing, manufacturing, testing, monitoring, and packaging, ensuring compliance with regulatory requirements.
  • Champion projects that enhance and promote the effectiveness and efficiency of the quality system and product quality, driving continuous improvement initiatives.
  • Promote a "right first time" approach to Quality Records, ensuring accountability for functional responsibilities.
About Abbott

Abbott Diabetes Care is a leading manufacturer of glucose monitoring systems, with a track record of innovation and development. We have a Global Centre of Excellence for Medical Devices based in Witney, Oxfordshire, where we manufacture substantial volumes of test strips annually and have been instrumental in the research, development, and manufacture of the next generation FreeStyle Libre Flash Glucose Monitoring System.

What We Offer

We offer a competitive salary, a defined contribution pension scheme, share ownership scheme, private healthcare, life assurance, and a flexible benefits scheme. As a member of our team, you will have the opportunity to develop your QA knowledge within a fast-paced, dynamic, and evolving environment, working on an exciting and complex new product. Problem-solving is a key feature of this position, along with the need for good communication skills. To be successful, you will need to be a decisive and solutions-oriented individual with a track record of successful achievements and accomplishments in a quality-related role in a regulated environment (such as medical devices, pharmaceutical, or healthcare manufacturing).

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