Manufacturing Quality Engineer | Roscomm

Collins Mcnicholas Recruitment

Roscommon

My client, a multinational in the medical device industry, is looking for an experienced manufacturing quality engineer to join their team. The role is reporting into the Head ofQuality. Responsibilities: Provide regulatory support for new product and support to Operations, Sterilisation and Labelling/Packaging. Review and update of Regulatory documentation to ensure compliance with current ISO standards, relevant FDA guidelines and EU Directives. Process Audits of the manufacturing lines to ensure the product being manufactured complies with all requirements, and that the Equipment/Process in use complies with the relevant Standard Operating Procedures. Identify and suggest improvements to current equipment, processes, and procedures to streamline the manufacturing activities while ensuring high standards of quality. In conjunction with the Manufacturing Engineer, provide advice and support to processes that require investigation or development with the goal to improve and make robust. Be an active Team Member on Continuous Improvement Projects by delivering on actions committed to, critiquing current methods, and suggesting alternatives/improvements. Support the Manufacturing Engineer and cross-functional teams on the collation of data and the resolution of processing issues. Actively promote Quality within the Manufacturing group, and assist the Quality Department on introducing initiatives into the Manufacturing Department. Lead Manufacturing Driven initiatives with respect to quality within the department. Batch Record/Lot History Review to ensure Product Compliance/GMP/GDP are as per relevant procedures prior to final QA Release. Maintain effective open communication within the team and foster cross-functional relationships. Conduct Training and Competence Assessment with manufacturing personnel on changes being introduced as required. Requirements: Primary degree or equivalent in Engineering/Science discipline. 4+ years experience in Medical device manufacturing. Must have a good working knowledge of production and quality system requirements. A Green or Black Belt in Lean Six Sigma would be a distinct advantage. For further information on this role please contact Mark on 071 914 2411 or email mark.whelan@collinsmcnicholas.ie. For more information on our Recruitment and HR Services, and to see a full list of our available jobs across Ireland, please visit our website at www.collinsmcnicholas.ie. Follow us on LinkedIn and connect with our consultants to discuss all the latest jobs! This job originally appeared on RecruitIreland.com.

1928 days ago