1+ months

Supplier QA Engineer

Witney, State Not Indicated

With a track record of innovation and development, Abbott Diabetes Care designs, develops and manufactures leading-edge glucose monitoring systems, for use in both home and hospital settings.

We have a Global Centre of Excellence for Medical Devices based in Witney, Oxfordshire. The site manufactures significant quantities of test strips annually and has also been instrumental in the research, development and manufacture of the next generation FreeStyle Libre Flash Glucose Monitoring System, launched in September 2014.

To support the manufacture of increased volumes of our latest product, we now have an exciting opportunity for an experienced quality professional to join our Quality Assurance & Compliance Group in the role of Supplier QA Engineer.

The key roles and responsibilities are as follows:

  • Select, qualify and maintain approved suppliers of the functional area.
    • Develop and maintain the supplier Quality System assessment schedule and lead and assist in the completion of assessment activities including onsite audits and questionnaires.
    • Review and track supplier performance and contact suppliers to discuss / resolve any adverse trends / issues identified.
      • Work with suppliers to resolve supply quality issues and agree the appropriateness of all associated CAPA plans from both audits and internal issues.
        • Approve Quality System records and documentation associated with Suppliers including change requests, the approved supplier list, technical agreements, specifications and procedures.
          • Ensure that the department remain compliant with local/divisional/corporate quality and compliance requirements and in a state of audit-readiness.

            Applicants will need a minimum of:

            • A Degree level qualification in a Technical/Quality discipline or equivalent work based qualifications in either the Medical Device or Pharmaceutical Industries.
              • A full driving licence

                Preference will be given to candidates with:

                • ISO9001/13485 audit training and/or experience.
                • Knowledge or experience of validation
                • Lead auditor status

                  In addition, to be successful, you will need to be able to demonstrate that you are:

                  • Confident and able to communicate at all levels
                  • Willing to challenge the status quo and take action by identifying and implementing improvements
                  • Independent and able to work without supervision, but also as an integral part of a team
                  • Able to initiate action, when required, to achieve departmental and project goals
                  • Diplomatic and trustworthy in their interpersonal dealings
                  • A positive, can-do attitude is vital

                    As you’d 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.
                    Job Family: Operations Quality
                    Division: ADC Diabetes Care
                    Travel: Yes, 10 % of the Time
                    Medical Surveillance: No
                    Significant Work Activities: Not Applicable


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Supplier QA Engineer

Witney, State Not Indicated

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Witney, State Not Indicated
United Kingdom

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