Quality Assurance / QA Engineer (Design and Validation)

Known globally for the development of revolutionary technologies, Abbott Diabetes Care designs, develops and manufactures glucose monitoring systems for use in both home and hospital settings. Abbott has been around for 135+ years, developing solutions for the world's health issues and creating a workplace that enables employees to live full lives.

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. This is an opportunity to make a difference and bring your best self to Abbott.

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. Here at Abbott, you can progress in your career by doing work that truly matters.

Responsibilities include:

• Define and support the validation strategy associated with varied site projects covering facilities, utilities, equipment and processes.
• Develop process validation and equipment qualification requirements (IQ, OQ, PQ) as part of design transfer activities.
• Review validation protocols with responsibility across equipment, production, facilities & utilities, analytical methods, sterilisation and shipping studies.
• 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.

To be successful, you will bring with you previous experience of validation processes, change control and risk management, ideally gained within the Medical Device or Pharmaceutical industry. You will also offer knowledge of cGMP, ISO13485, and 21 CFR 820. Ideally you will be degree qualified in an engineering, scientific or similar filed, however this is not essential. 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. This is a fantastic opportunity to become a valued member of a highly skilled Technical Quality Assurance team working in a fast growing area of our business.

Abbott has health/wellness and financial benefits that help provide security for you and your family . In addition to a COMPETITIVE SALARY, Abbott offers a highly ATTRACTIVE BENEFITS PACKAGE which includes a defined-contribution pension scheme, a share ownership scheme, private healthcare, life assurance, and a flexible benefits scheme which you can tailor to your own requirements. 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!

We politely request that Recruitment Agencies do not make contact in regard to this position.

Applications will be reviewed W/C 5th December.