Quality Engineer

Work Flexibility: Onsite Provide 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. * 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. * France * Engineering/Science licence and 2 years work experience in a quality discipline or * Engineering diploma (diplôme d'ingénieur) * Germany / Switzerland * Masters or Bachelor of Science, Engineering or related subject * Technician degree (or similar Level 6 Education like Meister) * Ireland / North America * 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 functionally Travel Percentage: 0%