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Quality Assurance Analyst

2 months ago


Nashville, United States Robert Half Full time

A growing manufacturing group in Nashville, TN is seeking for a Quality Assurance Analyst to join their team. The quality assurance analyst will support and maintain ISO guidelines and update compliance reporting. Additional responsibilities are below:


  • Implementing and managing quality control systems, ensuring compliance with ISO 17025, ISO 9001, and IATF 16949 standards.
  • Utilizing statistical process control to monitor product quality, recommending finished goods metrics.
  • Providing technical support to various departments to ensure customer satisfaction targets are met and communicated effectively among stakeholders.
  • Overseeing the hiring and training of Application and Process Support chemists for quality control and innovation labs.
  • Establishing and maintaining Standard Operating Procedures within the laboratories.
  • Managing day-to-day quality processes, ensuring documentation and activities align with QA and regulatory requirements.
  • Overseeing Document Control, Incoming Inspection, Non-Conforming Materials, Training, and Internal Audit activities, ensuring all comply with quality standards.
  • Leading supplier qualification programs and maintaining supplier rating records.
  • Managing agency audits, including the preparations and response plans for any observations.
  • Working alongside Regulatory Affairs to support agency regulatory requests, product registrations, and maintaining device listings.


Requirements:

  • Candidates should possess a BS or BA
  • 3-5 years of regulatory and ISO compliance experience
  • Demonstrate knowledge with Quality Regulations and QMS System in a manufacturing environment, and display exposure to inspections by regulatory authorities.