Senior Systems Quality Engineer

ICDS RECRUITMENT

WESTMEATH

Senior Systems Quality Engineer - County Westmeath. In this role you will lead and co-ordinate Quality Assurance activities to ensure customer specific requirements are captured and implemented to the relevant business processes. You will provide leadership in best practice in Quality and lead improvement projects to improve the QMS and reduce customer issues. You will also provide support to customers (on-site/remote) in the event of issues and take ownership of certain QMS processes. Core responsibilities include: • Monitor and ensure compliance with the relevant standards, including ISO13485. • Drive improvement and efficiency within the quality system, providing leadership to all teams on best practice in Quality. • Support of the Validation process. • Support risk management, risk analysis and FMEA processes. • Support Sales in ensuring that Customer Specific Requirements are captured effectively and understood. • Lead projects to implement Customer Specific Requirements in the relevant business areas where required. • Handle customer complaints, and other high value customers using 8D process. • Review and complete customer quality documentation accurately and in a timely manner, including Batch paperwork. • Lead improvement projects with cross-functional teams to continually improve QMS. • Support external audits. Qualifications and experience sought: • Experience of working in a Medical environment is essential. • 3rd level Qualification in Quality / Science / Engineering discipline. • At least 5 years’ experience working in a QA function, preferably in a medical device environment. • Excellent computer skills are required. • Strong project management skills. Lean Sigma green belt qualification would be a strong advantage.

1684 days ago