Senior Systems Quality Engineer

ICDS Recruitment

Westmeath

Senior Systems Quality Engineer- Westmeath. Key Purpose: Our Client is seeking a senior Qulity Engineer to lead and co-ordinate Quality Assurance activities to ensure Customer Specific Requirements are captured and implemented to the relevant business processes. The Ideal candidate will provide leadership in best practice in Quality and lead improvement projects to improve the QMS and reduce customer issues. They will also provide support to customers (on-site/remote) in the event of issues and take ownership of certain QMS processes. Key Responsibilities: 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 & Experience: Experience of working in a Medical environment is essential. 3rd level Qualification in Quality / Science / Engineering discipline. 5+ years’ experience working in a QA function, preferably in a medical. environment. Excellent computer skills are required. Strong project management skills. Lean Sigma green belt qualification would be a. strong advantage. Self-directed and results driven team player. Ability to work on own initiative, to deadlines, while also capable of working as part of a multi discipline team. Strong problem-solving skills and ability to handle multiple tasks in a fast-paced environment. Excellent interpersonal and communication skills, both written and oral with the ability to work effectively with staff at all levels of the organization. Excellent organisational skills, ability to take on and drive a project. A high level of flexibility is required. This job originally appeared on RecruitIreland.com.

1739 days ago