Senior Supplier Quality Engineer, Third Party Manufacturing
Location – Fermoy, Cork
About Abbott
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.
Abbott in Ireland
Abbott has beenoperatingin Ireland since 1946 and serves the Irish market with a diverse range of healthcare products including diagnostics, diabetes care, medicaldevicesand nutritional products. In Ireland, Abbott currently employs about 6,000 people across ten sites mostly locatedin Dublin, Donegal, Clonmel, Cootehill, Galway, Kilkenny,Longfordand Sligo.
Main purpose of the role
The position of Senior Supplier Quality Engineer is within our Abbott Diabetes Care Division, located in our Cork office. The Senior Supplier Quality Engineer will be responsible for activities related to Third Party Manufacturing (TPM) performance, monitoring and management. In this role you will provide QA leadership and expertise to Supplier Third Party Manufacturing. You will have the opportunity to work within a highly diverse, innovative team in a global organization with significant opportunities to develop your career further.
Main Responsibilities
* Support the maintenance of an effective Supplier Quality System
* Monitor Supplier performance per associated performance requirements
* Liaise on Suppliers quality issues and initiate/approve supplier corrective action Reports (SCARs) as required
* Using problem solving tools, conduct and support investigations as they arise from quality events, product complaints or other sources from the quality system ensuring root cause is determined and appropriate CAPA actions implemented
* Participate in Supplier Change Management and continuous improvement activities, including associated change control documents and Validation/Qualification activities
* Ensure compliance of Supplier quality system documents including, but not limited to Non-Conformances, Deviations and Quality Assessments, to division and global policies and procedures
* Mitigate risk by working with the Supplier to document Process Flow Charts, PFMEAs, and Control Plans
* Comply with regulatory requirements, Company policies, operating procedures, processes, and task assignments
Qualifications
* Bachelor’s degree in Engineering or Science (Master’s preferred).
* 4–8 years of relevant experience, at least 2 of which is in a regulated manufacturing environment.
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