Quality / QA Engineers - Operations and CAPA

3 weeks ago


Witney, United Kingdom Abbott Full time

With a track record of innovation and development, Abbott Diabetes Care designs, develops and manufactures leading-edge glucose monitoring systems, for use in both home and hospital settings.

We have a Global Centre of Excellence for Medical Devices based in Witney, Oxfordshire. The site manufactures substantial volume of test strips annually and has also been instrumental in the research, development and manufacture of the next generation FreeStyle Libre Flash Glucose Monitoring System, launched in September 2014.

To support the manufacture of increased volumes of our latest product, we now have a number of opportunities to join our Quality Team, some roles supporting Manufacturing Operations, and some specialising in CAPA.

The QAC teamwork closely with departments such as Operations, Technical, Engineering, R&D and Regulatory Affairs to achieve site 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 position involves dealing with shop floor quality issues as well as providing support to all aspects of the business to ensure objectives are met whilst maintaining compliance with the quality system.

Key responsibilities could include:

Supporting the CAPA process for the Witney Site Project managing Non-conformances, Potential non-conformances, and Deviations within agreed timelines Co-Ordinate 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 Support the tracking and trending of CAPA metrics Investigate, document and remediate Quality issues that arise; communicate and escalate as required Deliver the quality message around site through team training, presentations and tool box talks Support the monitoring and compliance of the Quality Management System as it applies to site Operations Plan, conduct and review inspections for all areas as per the inspection plan. Communicate findings and work with areas leads to implement corrective actions Support Operations to make Quality / Compliance decisions on product during processing, manufacturing, testing, monitoring and packaging Champion projects that enhance and promote the effectiveness and efficiency of the quality system and product quality Promote a “right first time” approach to Quality Records by ensuring accountability for functional responsibilities

This is an exciting opportunity to join a high-achieving team that offers structured career development opportunities within a state-of-the-art manufacturing facility 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-orientated 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).

As well as a proactive approach to your work, you will need to have excellent communication skills and sound judgement to take decisive action to resolve quality issues, and provide compliant yet practical solutions.

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.



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