About Abbott
Abbott is a global healthcare leader that helps people live more fully at all stages oflife. Our portfolio of life-changing technologies spans the spectrum of healthcare,with leading businesses and products in diagnostics, medical devices, nutritionalsand branded generic medicines. Our 113,000 colleagues serve people in more than160 countries.
Abbott serves the Irish market with a diverse range of healthcare products includingdiagnostics, medical devices and nutritionals products. In Ireland, Abbott employsover 6,000 people across ten sites. We have six manufacturing facilities located inClonmel, Cootehill, Donegal, Longford and Sligo and a third-party manufacturingmanagement operation in Sligo. Abbott has commercial, support operations andshared services in Dublin and Galway. We have been operating in Ireland since 1946.
Description
The Quality Engineer provides a support role to the Quality Manager in the routine maintenance of Abbott Rapid Diagnostic’s Quality Management Systems and in moderately complex Quality related projects.
12-month FTC
Responsibilities and Duties
* Possesses and applies a broad and increasing knowledge of Quality, and its application within Abbott Rapid Diagnostic, to the completion of moderately complex assignments.
* Broad knowledge of Abbott Rapid Diagnostic’s organization’s operations and practices to enable informed decisions in day to day operations and assignments.
* Applies problem-solving skills in order to deal creatively with complex situations, work that typically requires processing and interpreting, more complex, less clearly-defined issues. Identifies problems and possible solutions and takes appropriate action to resolve. Demonstrates skill in data analysis techniques by resolving missing/ incomplete information.
* Seeks consensus for decisions under conditions of uncertainty, sometimes with incomplete information, in order to produce effective end results. Applies risk assessment techniques in such circumstances.
* Drives business improvements through continuous improvement initiatives.
* Escalation point for quality related non-conformances and CAPAs.
* Drives compliance cross functionally in alignment with the regional objective for collaboration and multi-site ISO13485 certification.
Requirements
* Third level qualification.
* Minimum 5 years of experience in medical device industry with minimum 3 year of progressively responsible positions
* Competent working knowledge of recognized Quality Management Systems (e.g. ISO9001/ ISO13485/ ISO14971/ GMP),
* Awareness of relevant laws and regulations (e.g. CE/ FDA/ PAL)
* Broad knowledge of engineering and technical applications applied in development of medical devices useful.
Minimum Qualifications & Skills
* Excellent interpersonal, written and verbal communication skills, including ability to make clear, well founded decisions regarding conformity during audits.
* Pro-active attitude, excellent organization skills, and ability to manage multiple projects while delivering results on time.
* Proficient with MS Word, Excel, Power Point, and management of spreadsheets.
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