A medical device company in Dublin is seeking a Quality Engineering representative to ensure compliance with manufacturing processes and lead quality-related activities. The ideal candidate has over 5 years of experience in a cGMP environment and a degree in Science or Engineering. Responsibilities include providing quality support for product design and collaborating with internal departments and CMOs. The role offers a competitive salary and benefits, with a hybrid work model. #J-18808-Ljbffr
This role serves as Quality Engineering representative for medical device products and associated manufacturing processes. This position is responsible for collaborating with internal departments and external contract manufacturing organizations (CMOs) to ensure compliance. Additionally, this position shall lead and support Quality related activities and ensure effective implementation of improvements on identified projects/systems. Provide similar support for quality events, CAPAs, and audit records in eQMS. Provides audit and inspection support. Job Requirements Skills: Excellent communication, presentation, time management, cross-functional collaboration skills; attention to detail, multi-tasking, experience in medical devices, and strong computer skills (Word, Excel, PowerPoint, Minitab). Experience in: Quality with respect to manufacturing and design Validation Design Control Data Analysis and Statistical Techniques Investigations and Root Cause Analysis CAPA and NC Lean Six Sigma tools Experience: 5+ years in a similar role is strongly preferred, in cGMP, medical device, or regulated industry (including QA or engineering experience). Education: BS in Science, Engineering, or equivalent combination of Education, Experience and Competencies. Preferred Six Sigma Certification or ASQ Certified Quality Engineer Job Responsibilities Provide Quality support for design control and development activities for new products and design changes. Collaborate with Quality, R&D, and CMOs to use appropriate Six Sigma techniques during development and design changes (statistical sample plans, Gage R&R, DOE, process capability, reliability analysis, tolerance stack up, etc). Author and assist in providing design control deliverables to ensure development phase requirements are documented and compliant. Lead risk management activities for new product design and current product design changes. Collaborate in development of verification and validation plans and reports. Lead root cause analysis investigations on medical device products in conjunction with CMOs. Work with CMOs to identify and implement appropriate corrective actions to eliminate current problems and prevent future problems. Serve as Quality Representative for change control, quality events, CAPAs, and audit records in eQMS. Work with external CMOs to resolve technical issues as needed. Provide Supplier Quality functions. Qualify new suppliers, maintain Approved Supplier List (ASL), establish and maintain supplier audit schedule, and perform audits. Coordinate and facilitate Quality System Management Reviews. Serve as SME for internal audits and regulatory inspections. Competitive salary and benefits package. Opportunities for professional development and career growth. Collaborative and innovative work environment. Site/ Primary Work Location: Dublin D15, Ireland Primary Work Model: Hybrid Department: Quality Reporting to (Title): Director, Supplier Quality Hours: Full-time Travel Expectations: Up to 25%, as needed for CMO, Design, and audit/inspection support Physical Requirements: None Disclaimer: The included statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position. #J-18808-Ljbffr
