Quality Engineering Manager
2 months ago
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, nutritionals and branded generic medicines. Our 113,000 colleagues serve people in more than 160 countries.
Abbott serves the Irish market with a diverse range of healthcare products including diagnostics, medical devices and nutritionals products. In Ireland, Abbott employs over 6,000 people across ten sites. We have six manufacturing facilities located in Clonmel, Cootehill, Donegal, Longford and Sligo and a third-party manufacturing management operation in Sligo. Abbott has commercial, support operations and shared services in Dublin and Galway. We have been operating in Ireland since 1946.
Abbott Ireland Diagnostic Division Sligo
Abbott Diagnostic's is a global leader of in vitro diagnostics with approximately 70,000 institutional customers in more than 100 countries. Our diagnostic products offer a broad range of innovative instrument systems and tests for hospitals, reference labs, blood banks, physician offices and clinics.
Abbott’s diagnostic products offer customers automation, convenience, cost-effectiveness and flexibility. Abbott has helped transform the practice of medical diagnosis from an art to a science, helping to create the modern diagnostics industry through the company's commitment to improving patient care and lowering overall costs. The history of Abbott Diagnostics is filled with examples of first-of-a-kind products and significant technological advancements.
Job Purpose
Ensure that the AIDD, Sligo Plant meets it’s Customer, Division, Regulatory and Plant Quality goals through the effective management of the Quality Engineering department. The incumbent ensures the Quality Engineering group are effectively managed and all elements are in compliance with the requirements specified by Abbott Diagnostics Division Quality System and in the relevant applicable international standards. Ensure Environmental, Health and Safety standards are met and all EHS regulations and procedures are adhered to. Foster an awareness of Environmental Health & Safety in the plant and promote a culture of continuous improvement.
Major Responsibilities:
Through the effective management of the Quality group, ensure that the plant meets the quality requirements of its customers, ADD, Corporate, ISO and IVDD/IVDR Auditors and other external agencies. Complete all activities in a safe manner, ensuring that any potential safety issues and areas for improvement are addressed. Ensure Environmental Health & Safety standards are met and all EHS regulations and procedures are adhered to. Foster an awareness of Environmental Health & Safety in the plant and promote a culture of continuous improvement. Ensure Environmental procedures e.g. recycling, waste minimization is adhered to and improvements made where possible. Assist in the successful transfer/launch and start up of new products at AIDD Sligo. Participate, input and approve relevant NCRs, Investigations, CAPA’s, Internal Audits and ensure defined corrective and preventative action address root cause, are value added and are performed in a timely manner. Ensure prompt attention of the Site Quality Head in areas of risk, which may have an adverse effect on product quality/performance, project completion and/or safety. Assist and advise on pertinent Quality issues as they arise during plant operations. Participate as required in Quality Improvement Planning and provide guidance and leadership for improving and developing the processes within the Quality area. Participate in site Review Boards and provide relevant metrics/data for area of responsibility as required. Keep abreast of developments in quality and regulatory areas to ensure the plant continues to produce quality products under regulatory compliance. Maintain financial budget allocation to ensure area operates within agreed plans. Issue an area monthly report to the Site Quality Head. Annually, complete performance reviews/appraisals and growth plans for direct reports. On an annual basis, establish with Site Quality Head, the functional goals for area of responsibility. Update and review progress against goals on a quarterly basis. Management of Initiation, approval, distribution and timeliness of any required Risk Evaluations, Customer Communications or Field Actions. This activity will be coordinated in conjunction with the technical groups responsible for complaint investigation. Develop, support and manage the Quality Engineering group at the AIDD Sligo site including Validation / Calibration / Quality Approval /Risk management. Lead the rollout of the S-VMP and on an ongoing basis all site validations. Provide guidance and approval for all quality engineering decisions in AIDD Sligo.Minimum Requirements:
A third level degree qualification in Science, Engineering or a relevant Quality discipline. Validation experience is a pre-requisite 5 years post-graduate experience in commercial healthcare product manufacture/QA. Exceptional People Leadership experience Strong experience in the development or support of a Validation / Calibration systems. Experience in a Health Care Company preferably working with diagnostics.-
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