Quality Engineer II - CAPA job opportunity at Abbott.

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Abbott Quality Engineer II - CAPA
Experience: Highly Experienced
Pattern: full-time
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loacation United Kingdom - Witney, United Kingdom
loacation United Kingdom..........United Kingdom

      JOB DESCRIPTION: Job Title: Quality Engineer II - CAPA Location: Witney 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. We are seeking a proactive and detail-oriented CAPA Specialist to join our Quality team. In this role, you will be responsible for writing non-conformances, completing investigations, driving effective Corrective and Preventive Actions across the organisation to ensure compliance, improve processes, and support a strong culture of continuous improvement. The ideal candidate will have experience working within a regulated environment, strong problem‑solving skills, good technical writing skills, and the ability to collaborate across multiple departments to ensure timely, thorough, and sustainable CAPA implementation. Key Responsibilities Manage end-to-end CAPA processes, ensuring issues are documented, investigated, and resolved in line with internal procedures and regulatory expectations. Conduct root cause investigations using structured methodologies (e.g., 5 Why, Fishbone). Partner with cross-functional teams to develop effective corrective and preventive action plans. Monitor CAPA progress and ensure actions are completed within defined timelines. Verify and validate the effectiveness of implemented actions. Analyse quality data trends to identify systemic issues and drive continuous improvement initiatives. Support internal and external audits by providing CAPA-related documentation and subject matter expertise. Contribute to ongoing enhancements of quality processes and CAPA system performance. Requirements Experience in a quality or compliance role within a regulated industry (e.g., medical devices, pharmaceuticals). Strong understanding of CAPA processes and quality systems (ISO 13485, FDA 21 CFR Part 820) Proven experience conducting investigations and root cause analysis. Excellent communication skills, with the ability to influence and collaborate across teams. Strong organisational skills and attention to detail. Ability to manage multiple priorities and work effectively in a fast-paced environment. 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!       The base pay for this position is N/A In specific locations, the pay range may vary from the range posted.       JOB FAMILY: Operations Quality       DIVISION: ADC Diabetes Care          LOCATION: United Kingdom > Witney : Production Facility       ADDITIONAL LOCATIONS:       WORK SHIFT: Standard       TRAVEL: Yes, 5 % of the Time       MEDICAL SURVEILLANCE: Not Applicable       SIGNIFICANT WORK ACTIVITIES: Not Applicable                  

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