Quality Engineer - County Wexford
ICDS RECRUITMENT
Wexford
Quality Engineer - County Wexford. This is a contract posting of 18 months' duration. Purpose of the Role: Reporting to the Senior Quality Engineer, this individual will be a key member of the Supplier Quality team. The role requires a high level of ownership and enthusiasm. RESPONSIBILITIES: • Monitor and measure supplier product and process quality. • Manage supplier NCs, SCARs and improvement projects. • Provide quality direction to Receiving Inspection on component quality issues. • Support the ongoing supplier management activities such as maintaining Supplier Profiles & coordinating Documented Assessments. • Participate in supplier audit program as required. • Identify process improvement opportunities using analytical framework. • Apply creative problem-solving approach using statistical tools and techniques e.g. DMAIC. • Assess the supplier management process effectiveness through routine metrics and performance assessments. • Support EO sterilisation re-qualification and radiation dose audit programs to ensure continuity of validated processes and regulation compliance. Ability to work with the following is an advantage: • Lead/participate in continuous improvement/CAPA team activities. • Perform risk management activities in a cross-functional environment. • Ensure regulatory compliance in area of responsibility to cGMP’s. • Ensure that documentation and work practices comply with ISO and regulatory requirements. • Develop, maintain, and improve the quality management system. • Assess quality management system effectiveness through internal audit and performance review. • Excellent interpersonal skills with the ability to work in a team environment and work under own initiative to targets and deadline. • Problem solving techniques with excellent organisational skills. • Dedication to excellence, flexibility, attention to detail and adaptability to change. Required Qualifications and Experience: • Third level Technical / Science qualification plus minimum 2 years' experience in the medical device or pharmaceutical industry, preferably within supplier management. • Knowledge of quality management systems ISO 13485, GMP.
337 days ago