Quality Assurance Engineer, Senior

at  Abbott Laboratories

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 seven manufacturing facilities located in Clonmel, Cootehill, Donegal, Kilkenny, 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.

EDUCATION & COMPETENCIES

• National Framework of Qualifications level 7 qualification in a relevant discipline and 4+years of related work experience, or an equivalent combination of education and work experience.
• Wide application of technical principles, practices and procedures. Strong understanding of business unit function and cross group dependencies/relationships. 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 diverse scope where analysis of data requires evaluation of identifiable factors. Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Has a sound knowledge of various technical alternatives and their impact.
• Establishes and cultivates an extensive network of support to facilitate completion of assignments. Participates in the development of less experienced staff by setting an example, providing guidance and work direction, and offering counsel. May lead a project team. Participates in determining goals and objectives for projects. Influences middle management on technical or business solutions. May interact with vendors.
• Plans and organises non-routine tasks with approval. Initiates or maintains work schedule. Establishes priorities of work assignments. (Decision Making/Impact) Exercises judgment in selecting innovative, practical methods to achieve problem resolution. Failure to obtain results or erroneous decisions or recommendations would typically result in serious program delays and considerable expenditure of resources.
• Works under only general direction. Independently determines and develops approach to solutions. Work is reviewed upon completion for adequacy in meeting objectives.
• Will provide work direction and guidance to exempt and/or skilled nonexempt levels of employees will be asked to evaluate performance of and assist in career development planning for subordinates.

PURPOSE OF THE JOB

Provide Process/Quality Engineering support to manufacturing and projects 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. Will be the liaison to cross function departments (for example Research and Development, Operations and other Quality Functions). Must be able to analyze data and assist in interpreting the data. Develop and implement investigation process improvements.

MAJOR RESPONSIBILITIES

• Responsible for compliance with applicable corporate and divisional policies and procedures. Estimates project levels of effort and resource requirements by using standard estimating techniques and tools, and by working with appropriate staff to understand scope of effort.
• Prepares project plans, schedules and budgets by using project management tools such as Microsoft Project and by working with appropriate staff to understand tasks necessary to complete project.
• Directs project execution by assigning tasks, tracking project schedules, identifying risks, and developing and executing contingency plans.
• Communicates project status by preparing standard status reports, and by participating in departmental and customer project status update meetings.
• Resolves project issues by working with team members, project customers, and others as appropriate.
• Translates business strategy into meaningful objectives and day-to-day activities required to accomplish them.
• Identifies and controls manufacturing process defects (scrap, nonconforming material, customer complaints) by participating in efforts/teams focused on identifying the primary root causes and implementing corrective and preventative actions. May be responsible for querying and bounding data to support implementation of complex and documenting release criteria.
• Develops product quality plans, documents and systems by creating product specifications, quality specifications and quality plans in conjunction with other product development team members. May be responsible for creating risk analyses and Failure Mode Effect Analysis (FMEA).