Senior Quality Engineer

Job description

Work Flexibility: Onsite **23-month fixed term contract** Fully onsite in Carrigtwohill Provide quality engineering support and direction 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. • Will work within the quality operations team, under minimal supervision, 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. • Oversight and approval of NC & CAPA, activist and mentor in problem solving and root causing activities. • Lead and participate in the development and improvement of the manufacturing processes for existing and new products. • Analysis and review of concession requests. • Review and approval of change management activities. • Maintain KPI 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, proficient in the science of Human Factor identification and mitigation. • Proficient in risk management practices and tools, having high expertise in • process risk. Develop and provide input for risk management by identifying opportunities and weaknesses. • Proficiency in and makes continuous strides towards optimization of inspection methods and sampling. Support First Article Inspections. • Proficiency in statistical methods and application. • Participate and interface in internal & external audits with regulatory representatives, providing effective narrative and description of topic of expertise. • Assist in the development, responsible for review & approval of process and equipment validation/qualification. • Support manufacturing transfers to other plants/facilities, leading quality activities. • Responsible for initiation, management and support of Ship, Product Holds, potential product escapes. • Coach and mentor others in quality topics and activities. Qualifications Knowledge Skills • Bachelor degree in Science, Engineering or equivalent/ related subject and 2 or more years of work experience in a quality discipline, • Previous experience in a regulated environment desirable. • CQE or equivalent course work / experience desirable • Proficient in understanding of Med Device manufacturing processes desirable. • Familiarity with ISO 13485, GDP, GMP desirable. • Lean Six Sigma training a distinct advantage. • Excellent communication skills and attention to detail. • Have a good understanding of engineering and quality practices & methods. • High level of PC skills. Must be proficient with Microsoft Word, Microsoft Excel and PowerPoint packages. • Self-starter with demonstrated efficient work methods, analytical & problem solving skills 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. • Working knowledge/experience of Risk Based and statistical techniques, in particular process risk, statistical sampling plans, Process Capability, Gauge R&Rs. • Highly developed problem solving and strong 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. • Manages change well 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%