Abbott Quality Engineer (Data Integrity Project) in Clonmel, Ireland
Abbott in Ireland
In Ireland, Abbott employs almost 3,000 people across 10 sites. Abbott has six manufacturing facilities located in Clonmel, Cootehill, Donegal, Longford and Sligo and a third party manufacturing management operation in Sligo. It has commercial, support operations and shared services in Dublin. Abbott serves the Irish market with a diverse range of health care products including diagnostics, medical devices, nutritionals and branded generic pharmaceuticals. Abbott has been operating in Ireland since 1946.
Abbott Ireland Vascular Division – Clonmel
Abbott Vascular is one of the world's leading vascular care businesses. Abbott Vascular is uniquely focused on advancing the treatment of vascular disease and improving patient care by combining the latest medical device innovations with world-class pharmaceuticals, investing in research and development and advancing medicine through training and education.
Our broad line of vascular devices–which includes vessel closure, endovascular and coronary technologies–are used to treat vessel diseases of the heart, carotid arteries and peripheral blood vessels. These vessel diseases can lead to heart attack, stroke, critical limb ischemia and other serious vascular conditions.
We currently have a vacancy for 1 year contract for the role of Quality Engineer (Data Integrity Project) and this position will involve the following:
Provide Process/Quality Engineering support to manufacturing, helping to ensure delivery of highest quality product to the customer. Provide Process/Quality Engineering support to product development teams, helping to ensure development of highest quality new products.
Identifies manufacturing process defects (scrap, non-conforming materials, customer complaints) by dispositioning non-confirming material, identifying primary root causes and suggesting corrective and preventative actions. May be responsible for querying and bounding data to support implementation of basic product stops.
Assist in development of product quality plans, documents and systems by providing input to product specifications, quality specifications, quality plans, risk analyses, Failure Mode Effect Analysis (FMEA) in conjunction with other product development team members. May be responsible for providing input to risk analyses and FMEAs.
Becomes skilled at using process monitoring systems by starting to identify critical processes steps and applying basic methods to reduce process variation to reduce/eliminate the cause of defects.
Assists product/process improvement efforts (example, scrap, nonconforming product, customer complaints) by systematically gathering quality metric data based on previous program templates and by assisting in the appropriate analysis methods to enhance sustaining product design and new product development.
Becomes skilled at using quality tools in use
Participates in validation activity. Role may vary between providing input to owning activities such as protocol/report writing and managing execution of validation activities.
Participates in corrective and preventive action activity.
Participates in Field Discrepancy Notification (FDN) investigations. Education & Job skills
National Framework of Qualifications (NFQ) level 7 qualification in a relevant discipline and 2+ years of related work experience, or an equivalent combination of education and work experience.
Working technical knowledge and application of concepts, practices and procedures. General understanding of business unit/group function. Will perform this job in a quality system environment, Failure to adequately perform tasks can result in noncompliance with governmental regulations.
Works on problems of moderate scope where analysis of situations or data requires a review of identifiable factors. Exercises judgment within defined procedures and practices to determine appropriate action. Has a broad knowledge of technical alternatives and an understanding of their impact on the systems environment.
Cultivates a wide range of internal networks and begins to develop an extensive external network of resources to facilitate completion o task. May lead a project team of moderate scope. Provides guidance to less experienced staff. Acts as a mentor to lower level individual contributors. Influence exerted at peer level and occasionally at first levels of management.
Plans, organizes and priorities own daily work routine to meet established schedule
Exercises authority and judgment within defined limits to determine appropriate action. Failure to achieve results or erroneous decisions or recommendations may cause delays in program schedules and may results in allocation of additional resources.
Works under general supervision. Follows established procedures. Work is reviewed for soundness of technical judgment, overall adequacy and accuracy.
May provide limited work direction and guidance to exempt and/or skilled nonexempt levels of employees, may be asked to evaluate performance of and assist in career development planning for subordinates.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email firstname.lastname@example.org