Responsibilities

  • The overall focus of this role will be oversight of the Material Review Board (MRB) process for handling items identified as non-conforming or suspect.  Responsibilities include:
    • Maintain proper control and traceability of materials and non-conforming material
    • Ensure shortages created by non-conforming material, if not immediately available for replacement are highlighted as shortages and monitored for replacement on the work order from which they were identified as short
    • Follow-up with suppliers on return of material that has been reworked, replaced, or is being credited to Cogmedix
    • Coordinate shipment of returned material to suppliers, ensuring all appropriate paperwork is provided
    • Contact suppliers to obtain Return Material Authorization for non-conforming materials
    • Ensure appropriate level of sign-offs on disposition, especially of scrap material and material assigned a disposition of “use as is”
    • Ensure appropriate documentation associated with non-conforming material is in place
    • Working with a cross-functional team (Quality, Program Management, and Manufacturing Engineering), coordinate segregation, disposition and replenishment material identified by the production floor as being non-conforming or suspect, while performing all necessary ERP transactions
  • Other responsibilities may include:
    • Other support activities as assigned by the supply chain management team
    • Packaging of product as defined in customer supplied packaging procedures
    • Maintain the work area and equipment in a clean and orderly condition and follow prescribed safety regulations
    • Responsible for following cGMP and ISO 13485 requirements
    • Issue material to work orders
    • Kit work orders
    • Other non-MRB related ERP transactions as needed
    • Fill work order short requests
    • Receive incoming material and properly move to RII or a physical inventory – physically and systematically in the Cogmedix ERP
    • Coordinate Finished Sub-Assemblies (i.e., transacting sub-assemblies into Finished Goods and issuing to open Work Orders)

Essential Requirements

  • Positive attitude, self-motivator
  • Superior customer (internal and external) service attitude
  • Excellent teamwork and communication skills
  • Ability to multi-task in a high product mix, low to mid volume environment essential
  • Experience in medical device manufacturing preferred
  • Experience in Lean manufacturing environment preferred
  • Experience in basic manufacturing methods preferred
  • Must be able to read, write, and comprehend English
  • A demonstrated commitment to company values
  • High School Diploma or equivalent
  • Physical requirements:
    • Excellent manual dexterity and eye/hand coordination
    • Standing for prolonged periods of time
    • Sitting for prolonged periods of time
    • Ability to lift up to 30 lbs
    • Ability to physically move material throughout the organization