4 months ago
United Kingdom - Witney
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.
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 in the areas of design control and validation. You will play a key role in ensuring the transfer of new products and processes to manufacturing, as well as the ongoing maintenance of site quality systems.
Define and support design control activities in conjunction with R&D project teams for new biosensor product introduction (NPI).
Assist in the development, review and approval of design inputs and subsequent characterisation, design verification and validation protocols and reports.
Assist in completion of risk management reports utilising risk analysis tools such as FMEA and Root Cause Analysis.
Support the creation of Design History Files.
Take a key role in Design Reviews to assess quality and compliance for all project phases.
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.
Maintain an awareness of regulatory and industry best practice trends, hot topics and changes in relation to design control and 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. 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.
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.
We politely request that Recruitment Agencies do not make contact in regard to this position.
United Kingdom > Witney : Production Facility
Yes, 5 % of the Time
SIGNIFICANT WORK ACTIVITIES: