Overview
Bring your passion, ideas, and purpose to life in a company that can help you shape your career as you shape the future of healthcare. 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 manufacture of electrodes and biosensors used by patients and healthcare professionals for the day-to-day management of diabetes. As a result of strong business growth and industry-leading product development in the biosensor business we have an opportunity for a Quality Assurance (QA) Engineer to join our Technical Quality Assurance team. Serving as a primary representative for the Quality Assurance function on project teams, and supporting the R&D/Technical Services, Engineering and Operations areas, you will provide Quality Assurance expertise and guidance to ensure the validation of site products, processes and systems meets customer, business, and regulatory requirements.
Responsibilities
* Define and support the validation strategy associated with varied site projects covering either Facilities, Utilities, Equipment (FUE) and process or Non-Product Software (NPSW).
* Develop process validation and equipment qualification requirements (IQ, OQ, PQ) as part of design transfer activities.
* Review qualification / validation protocols with responsibility across either Facilities, Utilities & Equipment or Non-Product Software.
* Ensure the status of site validation system is established and maintained in accordance with internal procedures, regulatory requirements and industry guidance / standards.
* Support the implementation of change control documentation.
* Assist in completion of risk management reports utilising risk analysis tools such as FMEA and Root Cause Analysis.
* Maintain an awareness of regulatory and industry best practice trends, hot topics and changes in relation to validation.
Qualifications
To be successful, you will bring previous experience of validation, change control and risk management, in either the FUE or NPSW space, ideally gained within the Medical Device or Pharmaceutical industry. Your underpinning academic qualifications will likely be in the field of Engineering or a Science, supported by work-based experience in a similar role. A working knowledge of the Design Control process would be advantageous. You will also offer knowledge of cGMP, ISO13485, and 21 CFR 820. The ideal candidate will be a proactive individual who takes initiative and is able to work independently as well as part of a high performing cross functional team within a regulated, quality-driven environment.
Benefits
Abbott has health/wellness and financial benefits that help provide security for you and your family. As you\'d expect from an innovative global healthcare company, we offer an excellent starting salary, and a competitive range of benefits including a defined contribution pension scheme, share ownership scheme, private healthcare, life assurance, and a flexible benefits scheme.
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