QA Engineer - Technical
Witney (Oxfordshire) Design / Civil engineering / Industrial engineering
Job description
JOB DESCRIPTION:
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. We currently have an exciting opportunity for a Quality Engineer (Technical) to join our team.
Serving as a primary representative for the quality assurance function on project teams, and supporting the R&D/Technical Services areas, you will provide Quality Assurance expertise and guidance to ensure new product introductions and changes to products and processes meet customer, business and regulatory requirement.
You will be involved in reviewing, monitoring and maintaining Validation and Design documentation (including protocols and reports), change control and impact assessment documentation, and Risk Management plans, as well as providing input to sampling plans and statistical methods, and taking decisive action to resolve quality issues.
To be successful, you will bring with you previous experience of design and change control, validation processes, 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.
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, private healthcare, life assurance, and a flexible benefits scheme
JOB FAMILY:
Operations Quality
DIVISION:
ADC Diabetes Care
LOCATION:
United Kingdom > Witney : Production Facility
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
No
MEDICAL SURVEILLANCE:
Not Applicable
SIGNIFICANT WORK ACTIVITIES:
Not Applicable