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.
Key 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.
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• 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
• Other incidental duties: General work area housekeeping, attend training for new processes and procedures
Education and Experience:
H.S. Diploma or equivalent Preferred
2 years experience previous related experience Required
Previous medical device assembly experience
Additional Skills:
• Full understanding of applicable inspection procedures
• Ability to continuously expands 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
• 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
• Strict attention to detail
• Adhere to Edwards Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing
• Must be able to work with minimum supervision
• Work in a Team environment
• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) 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