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Supplier Quality Engineer

San Diego, CA

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RemX is hiring experienced Supplier Quality Engineers to join a leading developer of in-vitro diagnostic devices based out of San Diego, CA.  These are long-term contract positions expected to last 18 months or longer.  Successful candidates should have a solid background in medical device manufacturing, including knowledge of 21 CFR 820 and ISO 13486, and excellent communications and organizational skills.


Primary Responsibilities:

  • Work closely with new and established suppliers to ensure effective monitoring of supply chain performance
  • Support the qualification of new suppliers including creation and management of quality agreements with vendors
  • Perform supplier audits and manage supplier corrective actions (SCAR’s) when necessary
  • Manage supplier change control and work with the Operations and Quality teams to evaluate impacts of change on product performance

Job Requirements

  • Bachelor’s Degree in Engineering, Biotechnology, or a related scientific or engineering field
  • 5-10 years’ related Quality or Supplier Quality experience in the medical device field
  • ASQ Certified Quality Engineer or equivalent preferred
  • Working knowledge of regulatory requirements and quality systems (21 CFR Part 820, ISO 13485, ISO 14971:2012, CMDR)
  • Working knowledge of process validation and design control
  • Experience in root cause analysis and corrective action processes
  • Working knowledge of the technical aspects of in-vitro diagnostic device functions


Additional Information

Location: San Diego, CA

Position Type: Contract

Pay Range: $32-43 per hour based on experience

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