Quality Engineer Job In Tullamore

Job Description

We are seeking a Quality Analyst to assist in the administration of our quality management system, ensuring adherence to regulatory standards and driving continuous improvement initiatives. **Job Responsibilities:** * Assist in the administration of the quality management system to ensure adherence to ISO 9001, ISO 13485, FDA 21 CFR Part 820/211, EU GMPs, ISO 17025, ISO 11137 and/or ISO 11135 and other applicable regulatory standards. * Lead complaint/CAPA investigations, supplier quality improvement initiatives, and continuous improvement initiatives using statistical techniques and quality principles. * Execute activities related to the development, implementation, maintenance, and continuous improvement of STERIS quality systems. * Support production and quality operations by coordinating and performing problem-solving investigations, pre-reviews, and final acceptance/run release of processing runs that contain non-conformances. * Ensure quality and regulatory compliance to meet product processing requirements in accordance with customer specifications, including calibrations, dosimetry results, generation of test methods, audits, scheduling, validations, record keeping, and reporting. * Coordinate day-to-day tasks and direction for Quality Technicians/Senior Quality Technicians by providing technical support, mentoring, and oversight. * Oversee all product and/or report pre-reviews and releases conducted by Quality Technicians/Senior Quality Technicians. * Execute product and/or report releases for all processing runs/lab samples containing a non-conformance, including management of customer communication and leading the associated non-conformance investigations. * Initiate and/or participate in corrective actions, problem-solving, and continuous improvement activities. * Perform internal audits at other AST facilities, including identification of non-compliances and report generation. * Manage remediation of internal audit observations assigned by site Quality Manager. * Manage creation of new quality system policies and procedures and revisions to existing policies/procedures. * Review collected data to perform statistical analysis and recommend process changes to improve quality. * Monitor and report on performance metrics. * Instruct other STERIS employees in quality principles, effective corrective actions, and valid statistical techniques. * Collaborate with other departments and facilities within the company on quality-related issues. **Requirements:** * Bachelor's Degree * 1-5 years of combined Manufacturing/Quality Engineering and/or Quality Systems experience or minimum of 6 months on-site STERIS internship or co-op experience * 1-5 years of experience with medical device or other regulated industries preferred * 1-5 years of experience working in an ISO certified environment required * Working knowledge of FDA QSR/EUGMP regulations strongly preferred * Excellent problem-solving skills * Focus on identification of potential issues and continuous improvement * Experience working on cross-functional teams and on own initiative * Demonstrated excellent organizational, oral, and written communications skills * Must have PC experience, as well as working familiarity of desktop applications including Excel, Word, and Power Point * Ability to work in a fast-paced, regulated environment with strict deadlines * Mathematical skills including practical application of fractions, percentages, ratios, proportions, and algebra