MFG Inspector-
Edwards Lifesciences
Cartago, Costa Rica
hace 2 días

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 and as assigned by Leadership
  • Education and Experience :

    H.S. Diploma or equivalent Required

    Additional Skills :

  • Basic computer skills
  • Ability to read, comprehend, and speak English, and good communication skills, required (medium level)
  • 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
  • Strict attention to detail
  • Adhere to Edwards Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing
  • Ability to work with minimum supervision
  • Ability to work in a team environment
  • Ability to effectively provide and accept feedback from colleagues
  • Ability to provide feedback on product defects and may follow through to establish resolution
  • 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
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