Quality Engineer II CAPA
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Job Location:
Oxfordshire - UK
Monthly Salary:
Not Disclosed
Posted on:
6 hours ago
Vacancies:
1 Vacancy
Job Summary
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 its 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 peoples lives.
We are seeking a proactive and detail-oriented CAPA Specialist to join our Quality 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 problemsolving 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 youd 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 employees 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/AIn 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
Required Experience:
IC
Key Skills
- APQP
- Quality Assurance
- Six Sigma
- ISO 9001
- PPAP
- Minitab
- Root cause Analysis
- ISO 13485
- Quality Systems
- Quality Management
- As9100
- Manufacturing
About Company
WHO WE ARE CREATING LIFE-CHANGING TECHNOLOGY From removing the regular pain of fingersticks as people manage their diabetes to connecting patients to doctors with real-time information monitoring their hearts, from easing chronic pain and movement disorders to testing half the world’s ... View more
