Overview
CAPA Quality Engineer – Location: Witney, Oxfordshire. Abbott Diabetes Care in Witney is looking for a passionate and detail-oriented Quality Engineer to join the Quality Assurance CAPA Team. This pivotal role focuses on maintaining compliance with global regulatory standards through effective management of Corrective and Preventive Actions (CAPA). The role emphasizes data collation, analysis, and driving continuous improvement across quality systems to support patient safety and product excellence.
The successful candidate will lead non-conformance impact assessments and investigations in line with divisional procedures, collaborating with cross-functional teams to facilitate thorough root cause analysis using recognised methodologies such as 5 Whys, Fishbone, and FMEAs. You will develop and implement robust corrective and preventive action plans, ensuring timely closure and monitoring effectiveness. Your work will span across departments and divisional CAPA teams, ensuring integration and alignment within the wider quality system. You will generate and present metrics to support CAPA tracking and trending, contributing to Site Management Review (SMR) and Abbott Management Review (AMR). Through analysis of quality data, you will identify trends and systemic issues to inform strategic improvements and uphold high standards of patient safety. Proficiency in Excel to generate meaningful metrics and insights is expected to support continuous improvement and quality system excellence.
This is an exciting opportunity to join a fast-paced and innovative environment at our Witney site, a Centre of Excellence for the manufacture of electrodes and biosensors used in diabetes management. The site contributes to the development and production of the FreeStyle Libre Continuous Glucose Monitoring System, including Libre 2, Libre 3 and Libre Sense.
Responsibilities
* Lead non-conformance impact assessments & investigations in line with divisional procedures, collaborating with cross-functional teams to facilitate thorough root cause analysis using recognised methodologies (e.g., 5 Whys, Fishbone, FMEAs).
* Develop and implement robust corrective and preventive action plans, ensuring timely closure and monitoring effectiveness.
* Ensure integration and alignment of CAPA activities across departments and divisional teams within the wider quality system.
* Generate and present metrics to support CAPA tracking and trending, contributing to Site Management Review (SMR) and Abbott Management Review (AMR).
* Analyse quality data to identify trends and systemic issues and support strategic improvements to uphold patient safety.
* Utilise Excel to generate meaningful metrics and insights for continuous improvement and quality system excellence.
Qualifications / Requirements
* Experience in CAPA, quality systems, and regulatory compliance within a medical device environment.
* Strong data analysis skills with ability to translate data into actionable insights.
* Proficiency in Excel; ability to generate metrics and support improvements.
* Ability to work cross-functionally and communicate effectively with diverse teams.
About the Site & Benefits
Abbott offers professional development opportunities and a competitive benefits package including a defined contribution pension, private healthcare, life assurance, share ownership options, and a flexible benefits platform tailored to individual needs.
The base pay for this position is N/A. In specific locations, the pay range may vary from the range posted.
Job Details
* JOB FAMILY: Operations Quality
* DIVISION: ADC Diabetes Care
* LOCATION: United Kingdom > Witney: Production Facility
* ADDITIONAL LOCATIONS: N/A
* WORK SHIFT: Standard
* TRAVEL: Yes, 5% of the time
* MEDICAL SURVEILLANCE: Not Applicable
* SIGNIFICANT WORK ACTIVITIES: Not Applicable
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