Quality Engineer - County Waterford

ICDS Recruitment

Waterford

Quality Engineer - County Waterford. In this role you will be instrumental in providing support to the Manufacturing Quality Manager to ensure that equipment is maintained & product is produced in compliance. You will ensure that the quality management system is adhered to at all times, and that all directives, policies and procedures are complied with. Duties & responsibilities include: To provide support to the Manufacturing Quality Manager in maintenance, review and improvement of the quality management system. To provide quality oversight for machine moves, validation, PFMEA and risk assessments. Ensure Non conformances and associated CAPA’s are tracked and managed. Participate in Quality System Improvement programme. To liaise with internal and external stakeholders to ensure that the quality system is maintained during all stages of manufacturing. Act as the Quality Lead for specific lines , issues as required & CAPAs. Understand and review Validation documentation, Change Requests, Design and Process FMEA’s, NCs & CAPA. Participate in Quality System Continuous Improvement activities. Ensure regulatory compliance to GMP’s of applicable medical device regulatory agencies (eg, FDA, ISO and MDD. Maintain/Improve good documentation practices for Work instructions, SOP’s and Forms. Interested applicants should have: Third level Qualification in Science or Engineering -Degree level. Statistics/Six Sigma qualification desirable. Good communication skills. The ability to motivate and influence people. Self starter, highly motivated with the ability to prioritize. Ability to work on own initiative. High attention to detail. Minimum 3-5 years experience in a regulated pharmaceutical/medical device environment. Medical device QA experience highly desirable. Validation experience desirable. Full understanding of the requirements of the Regulatory Standards. Experience of team working. This job originally appeared on RecruitIreland.com.

2766 days ago