Senior Quality Engineer - County Galway
Senior Quality Engineer - County Galway. In this role your primary responsibility will be to assure conformance to established requirements and standards for products and processes through the effective implementation of the Quality Management System processes. This will entail directing and/or supporting the Quality Management System processes, including but not limited to Corrective and Preventive Action, Audits, Supplier Quality Management and Validation. You will interact with many different functional departments, suppliers, and experts outside the company in order to communicate and implement Quality Objectives. Principal Duties and Responsibilities: Developing and implementing processes, procedures and instruction to sustain and improve the Quality Management System. Supporting Management in the development and implementation of quality systems strategies and objectives. Identifying and solving product and process problems. Supporting various operational / manufacturing groups and suppliers in resolving and preventing quality issues. Performing quality engineering analysis and responses for corrective/preventive actions. Working with suppliers, manufacturing, engineering, and other functional areas to assist and verify the implementation and effectiveness of the corrective/preventive actions taken for non-conformance. Conducting audits and assessments of internal processes and suppliers' manufacturing sites. Developing validation strategies and support the successful execution of same. Supporting and representing the site during external regulatory audits. Interested applicants must be familiar with all aspects and elements of a quality system , including but not limited to management responsibility, resource management, product realisation and measurement, analysis and improvement processes. Knowledge on aspects of quality assurance techniques such as: inspection methods, statistical sampling plans, gauging and test methods concepts, validation, and statistical process control. Demonstrated technical expertise. Able to work independently or as part of a team. Strong written and verbal communication skills. Education/ Experience Requirements. Bachelor’s degree in engineering is required or an alternative Bachelor’s degree with certification as a Quality Engineer. Must have minimum of 5 years' experience in Quality Engineering field. Experience of working in a regulated industry, preferably medical devices.
8 days ago