Quality Engineer

ORION GROUP

LIMERICK

Orion Group Sciences have an exciting opportunity for a Quality Engineer for our multinational medical devices client based in the Limerick area on an initial 12-month contract. Job Purpose. Provides support to root cause investigation activities, and ensures good Quality Engineering practices are used in investigations. Drives continuous improvement through data driven approaches and monitoring of quality systems. Main Responsibilities of the role. Provides complex product team support for quality system design and audit, compliance assessment, and for support of steady state manufacturing processes. Utilizes multifaceted industry and process excellence standards on an expert level in daily quality operations, including good manufacturing practices (GMP), equipment engineering system (EES), and international organization for standardization (ISO. Reports on contract manufacturer performance metrics and ensures management reviews. Oversees audits of all quality system categories to assess compliance to process excellence standards. Ensures comprehensive measurement systems to monitor effectiveness of quality and reliability systems to identify, bracket, correct and prevent defects, presenting reports to management. Handles complex technical issues for manufacturing processes that are to be transferred to satellite facilities. Responsible for supporting the activities of Operations/Engineering/information management in building quality into our products and assuring compliance to the pertinent regulations while at the same time attaining operational effectiveness. Support QA programs in assuring compliance to the pertinent regulation. Identify and lead cost and technical improvements under the departments' continuous improvement program. Lead or actively participate in cross-functional teams to ensure New Product Introduction/Research and Development projects are completed in a timely and efficient manner. Actively interfacing with cross-functional team members, always practicing good team work in support of day to day operating requirements. Ensure effective closure on Quality System documents (Audit Actions, NCR's, CAPA's, Maps, etc.) Ensure all process developments, NPI etc. are managed in accordance with the Quality management system. Implementation of safety/environmental requirements on purchase of all new equipment. Desired Experience and Background of the successful candidate. Degree Qualified in Science/Engineering. Relevant experience working in manufacturing/operations. Excellent working knowledge of process excellence / QE tools such as pFMEA , SE , statistical analysis , SPC. CAPA and RCI experience. Excellent IT skill eg , experience in minitab , excel reports. Automated process controls experience. Good presentation skills. The ability to think on the feet and providing sound judgment is highly desired. #medicaldevices #medical #device #13485 #multinational #product #implant #NPI #quality #engineer #qualityengineer #GMP #EES #ISO #pFMEA #CAPA #RCI. For more information on this role, call Shane O' Neill on 353 (0) 212063407 or email Shane.ONeill@orioneng.com@orioneng.com for a completely confidential chat about this role and other opportunities using the reference number: 929589. Our role in supporting diversity and inclusion. As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.

1547 days ago