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Medical Device Receiving Inspector

Company: Unitek Technical Services
Location: San Francisco
Posted on: May 28, 2023

Job Description:

Unitek Technical Services provides supplier management, development, and related technical services to corporations around the world.
We are currently seeking Medical-Device Receiving Inspectors to work on-site at a client's facility in Irvine, CA .
Job Description:
Experienced and trained inspectors with minimum 5 years' experience as Med-device inspector to be able to 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. Inspector should perform verification of receiving documents with component and device drawings to ensure requirements are met, also review, follow and perform job functions in compliance with established work instructions.
Required 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 Essential Job Functions
    • 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 (45% of time)
    • Perform verification of receiving documents with component and device drawings to ensure requirements are met (20% of time)
    • 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. (15% of time)
    • Control inventory to ensure appropriate storage conditions and movement, as well as ensuring correct labeling of product status. (10% of time)
    • Train colleagues from other sites, including inspection of their work output (5% of time) Additional Notes:
      • Location: Edwards Lifesciences Corp. in Irvine, CA
      • Frequency: 40 hours/week (Second Shift: 2:15PM - 10:45PM)
      • Duration of the contract: Varies (Minimum 1 month at a time) Opportunities for 3 mo., 6 mo., 1 yr. etc. as needed.
      • Start Date: Immediate
      • W2 Contract
        #ZR

Keywords: Unitek Technical Services, San Francisco , Medical Device Receiving Inspector, Professions , San Francisco, California

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