Quality Engineer page is loaded## Quality Engineerlocations: Cork, Irelandtime type: Full timeposted on: Posted Todayjob requisition id: R548110Work Flexibility: Hybrid**18 Month FTC**## Position SummaryProvide quality engineering support in quality assurance, control and preventative activities within operations and other business functions, with a focus on preventative measures and continuous improvement of products and processes. Advocate and lead the execution of initiatives & projects to enhance quality performance within the business. Ensure compliance to regulation and standards.## Position RequirementsWill work within the quality operations team, with moderate supervision and mentoring, with responsibility for quality related activities, including, but not limited to the following:* Work closely with operations and the business functions to ensure quality performance of product and processes.* Approval of NC, builds proficient in problem solving and root causing activities.* Participate in the development and improvement of the manufacturing processes for existing and new products.* Review of change management activities.* Maintain KPIs for monitoring of process quality, perform analysis and interpret trends, take action as necessary.* Support execution and analysis of QATs.* Advocate of Human Factor practices, familiarity in the science of Human Factor identification, reduction and mitigation.* Develop understanding of risk management practices and concepts, ability to become proficiency in process risk.* Develop understanding of optimization of inspection methods and sampling. Support First Article Inspections.* Developing proficiency in statistical methods and application.* Participate and interface in internal audits providing effective narrative and description of topic of expertise, participate in external audits preparation building confidence and proficiency in interactions with same.* Assist in the development and review of process and equipment validation/qualification. Build proficiency in validation processes.* Support manufacturing transfers to other plants/facilities, execution quality activities.* Responsible for initiation, internal containment and support of ship and product holds for potential product escapes.## Qualification Knowledge Skills* Masters or Bachelor of Science, Engineering or related subject* Previous experience in industry desirable* Understanding of Med Device concepts desirable.* Familiarity with ISO 13485, GDP, GMP concept desirable.* Excellent communication skills and attention to detail.* Have a good understanding of engineering and quality concepts / theories.* High level of PC skills. Must be proficient with Microsoft Word, Microsoft Excel and PowerPoint packages.* Self-starter with efficient work style and ability to handle multiple tasks in a fast paced environment.* Must be willing to work as part of a multi-site team, with some travel required.* Knowledge of Risk Based and statistical concepts desirable.* Problem solving and analytical skills.* Builds strong relationships by fostering open communications, respect and trust. Strong team player and acts with a customer service/stakeholder focused approach* Is diplomatic, tactful and leverages excellent interpersonal keys to help achieve outcomes.* Accepts change openly and adopts a continuous improvement orientation to the role* Excellent English (both oral and written)* Ability to be the voice of Quality when dealing cross functionallyTravel Percentage: 10%
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