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Abbott Senior CAPA QA Engineer (3) in Witney, United Kingdom

Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health.

World Leader in Glucose Monitoring, Abbott Diabetes Care designs, develops and manufactures glucose monitoring systems for use in both home and hospital settings. We have a Centre of Excellence in Witney for the development and manufacture of electrodes and biosensors used by patients and healthcare professionals for the day-to-day management of diabetes. The site has been instrumental in the research, development and manufacture of the FreeStyle Libre Flash Glucose Monitoring System as well as exciting developments in the Libre family including FreeStyle Libre 2, FreeStyle Libre 3 and the Libre Sense system. We are passionate about doing work that improves the quality of people’s lives.

To support the continued volume manufacture of our latest product, we have an exciting opportunity for a Senior Quality Engineer to join our team in the role of QA Engineer 3 – CAPA with a key focus on Management of the ADC CAPA process.

The Quality Assurance team work closely with departments such as Operations/Manufacturing, R&D, Technical, Engineering, and Regulatory Affairs to achieve project goals relating to the development, manufacture, and delivery of quality and compliant products on time, in full and cost effectively.

This role offers the successful candidate the opportunity to develop their QA knowledge within a fast paced, dynamic, and evolving environment. The key responsibilities in this role are:

  • Manage the CAPA process for the Witney site and support the Division CAPA process.

  • Responsible for the CAPA process for the Witney Site

  • Project managing Non-conformances, Potential non-conformances, and Deviations within agreed timelines.

  • Manage cross functional team activities to ensure investigations establish root cause and identify appropriate corrective actions.

  • Project manage CA/PA / Corrections / Effectiveness Checks within the CAPA system to agreed deliverables and timelines.

  • Manage the tracking and trending of CAPA metrics.

The ideal candidate will be educated to Secondary Level including English and Maths or an appropriate Quality Qualification to enable the incumbent to generate clear and legible documentation, understand Technical Information and make appropriate risk-based decisions. Prior experience of the development and / or manufacture of regulated products to ensure familiarity with cGMP and / or ISO system requirements. Please note that this is not a software role.

As you’d expect from an innovative global health care company, we offer an excellent range of benefits including competitive salaries, a defined contribution pension scheme, share ownership scheme, private healthcare, life assurance, and a flexible benefits scheme. Here at Witney, we also like to help our employee’s live life to the fullest, and therefore we offer a range of optional initiatives for you to get involved in, including onsite allotments, couch to 5k campaigns, bee keeping, yoga and more!

An Equal Opportunity Employer

Abbot welcomes and encourages diversity in our workforce.

We provide reasonable accommodation to qualified individuals with disabilities.

To request accommodation, please call 224-667-4913 or email corpjat@abbott.com

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