Assesses devices in-process and upon completion to ensure regulatory and company guidelines have been met and devices meet operational standards as designed.
Key Responsibilities:
• Perform visual, dimensional, and functional inspection of components and/or finished medical device products using a wide variety of tools and equipment such as magnifying lamp, microscope, vision inspection system, etc. to ensure conformance with design specifications
• Perform functional testing of finished medical device products using both automated and manual valve testing equipment to ensure conformance with design specifications
• Review, follow and perform job functions in compliance with established work instructions and adherence with SOPs, including recording traceable information on device history records and may enter information into JDE.
• Perform verification of manufacturing documents with component and device drawings
• May control inventory to ensure appropriate storage conditions and movement
• May train colleagues from other sites, including inspection of their work output
• Other incidental duties: General work area housekeeping
Education and Experience:
H.S. Diploma or equivalent 0 years experience No previous related exp. required Preferred
Additional Skills:
• Ability to use applicable tools and equipment, hand eye coordination, and high manual dexterity
• Basic level of understanding of inspection procedures
• Ability to effectively provide and accept feedback from colleagues
• Good communication skills
• Able to read, comprehend, speak, and write English
• Basic computer skills, preferred
• 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