Job Information
Abbott Quality Assurance Engineer in Clonmel, Ireland
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 nutritional 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 product development teams, helping to ensure development of highest quality new products.
Key Responsibilities:
Responsible for creating/reviewing engineering protocols and reports, including standard statistical analysis of data.
Assists in development and implementation of product quality plans, documents and systems by creating product specifications, quality specifications and quality control plans.
Responsible for creating risk analysis and FMEA (Failure Mode and Effects Analysis), in conjunction with other product development team members, and ensuring adequate risk analysis and risk control measures and implemented throughout the design and development process.
Collects and completes analysis of quality metric data (for example customer complaints, nonconforming product, scrap). Assists in product/process improvement efforts by systematically gathering quality metric data and performing the appropriate analysis method(s) to enhance sustaining product design and new product development.
Lead root cause analysis investigations and implement corrective and preventive actions.
Assists in development and implementation of Process Monitoring plans by identifying critical process steps which could culminate in possible sources of manufacturing defects and devising methods to reduce process variation in order to reduce/eliminate the cause of defects.
Provides input when developing strategies for design control deliverables/elements that satisfy both regulatory requirements and business needs in conjunction with other product development team.
Assists in the preparation of regulatory filings/submissions, to meet geography/country specific requirements, in conjunction with Regulatory Affairs (RA).
Assists in creation of quality tools and training materials by applying body of knowledge/expertise and communicating to respective teams.
Responsible for execution or modification of test methods or their validations to provide evidence of product conformity to established requirements.
Education & Job Skills:
(Education/Experience) 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
(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 practices to determine appropriate action. Has a broad knowledge of technical alternatives and an understanding of their impact on the system 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 level of management.
(Planning/Organisation) Plans, organises, and priorities 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.
(Supervision Received) Works under general supervision. Follows established procedures. Work is reviewing for soundness of technical judgment, overall adequacy and accuracy.
(Supervision Provided) May provide limited work direction and guidance to exempt and/or skilled non-exempt levels of employees, may be asked to evaluate performance of an 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 corpjat@abbott.com