Edwards Lifesciences RI Inspector in Shannon, Ireland
Innovation. Relationships. Passion. Caring. It’s who we are. It’s personal.
Edwards thrive on discovery and expand the boundaries of medical technology. We are passionate about providing innovative solutions for people fighting cardiovascular disease. It's our Credo. It takes integrity, collaboration, innovation, and focus.
Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world’s leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives.
Edwards Lifesciences have been established in Ireland since 2018. With the opening of our state-of-the-art facility in Castletroy, Edwards are now going through a period of significant growth.
The Receiving Inspection Inspector assesses components and devices upon receipt to ensure regulatory and company guidelines have been met, and that the components and devices meet operational standards as designed.
Essential Duties and Responsibilities:
Perform visual, dimensional, and functional inspection of components and devices using a wide variety of applicable instruments and equipment such as magnifying lamp, microscope, vision inspection system, calipers, etc. to ensure conformance with design specifications, working at a level greater independence with a higher level of productivity.
Perform verification of receiving documents with component and device drawings to ensure requirements are met.
Review, follow and perform job functions in compliance with established work instructions (i.e., routers) and adherence with SOPs, including recording traceable information on device history records and entering information into JDE.
Control inventory to ensure appropriate storage conditions and movement, as well as ensuring correct labeling of product status.
Train colleagues from other sites, including inspection of their work output.
General work area housekeeping, attend training for new processes and procedures.
Good communication skills.
Strong English language skills, including reading, comprehending, speaking, and writing, and strong communication skills.
Proficient computer skills, including strong working knowledge of manufacturing software.
Full understanding of applicable inspection procedures.
Ability to continuously expand proficiency in inspection techniques.
Ability to use applicable instruments and equipment, hand eye coordination, and high manual dexterity.
Ability to clearly describe and convey nonconformance issues and enter them into QMS (Quality Management System).
Ability to effectively provide and accept feedback from colleagues on independent data verification.
Ability to provide feedback on product defects and follow through to establish resolution
Strict attention to detail.
Must be able to work in a Team environment with minimum supervision.
Adhere to Edwards Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing.
Adhere to all EHS rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control.
Leaving Certificate or equivalent.
2+ years of previous related experience.
Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 15,000 individuals worldwide.
For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.