Intermediate Quality Engineer

3 months ago

Clonmel, Ireland Abbott Full time

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 in Ireland

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.

Purpose Statement:

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.

Main Responsibilities:

1. Identifies manufacturing process defects (scrap, non-conforming mate rial, customer complaints) by dispositioning non-conforming 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.

2. Assists 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 Failure Mode Effect Analysis ' (FMEAs).

3. Becomes skilled at using process monitoring systems by starting to identify critical process steps and applying basic methods to reduce process variation to reduce/eliminate the cause of defects.

4. 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.

5. Becomes skilled at using quality tools and training materials by working with existing quality tools and training materials and by understanding evolution/history of tools in use.

6. Participates in validation activity. Role may vary between providing input to owning activities such as protocol/report writing and managing execution of validation activities.

7. Participates in corrective and preventive action activity.

8. Participates in Field Discrepancy Notification (FDN) investigations.

Education & Experience:

(Education/ Experience) National Framework of Qualifications (NFQ) level 7 qualification in a relevant discipline. 2+ years of related work experience, or an equivalent combination of education and work experience (Technical/Business Knowledge (Job Skills)) 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. (Cognitive Skills) 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. (Influence/Leadership) Cultivates a wide range of internal networks and begins to develop an extensive external network of resources to facilitate completion of tasks. 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. (Planning/Organisation) Plans, organises, and prioritises own daily work routine to meet established schedule. (Decision Making/Impact) 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 result in the allocation of additional resources.

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