Quality Engineer page is loaded## Quality Engineerlocations: Cork, Irelandtime type: Full timeposted on: Posted Todayjob requisition id: R******Work 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 *****, 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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