Quality Assurance Technician

4 weeks ago


Chicago, United States Medix™ Full time

Quality Assurance Technician


Location: Northfield, IL

Pay: $27/HR

Shift: Monday - Friday, 8AM to 5PM (Opportunity to work remotely Monday+Friday)


QUALIFICATIONS:

  • Bachelor of Science in Biology or related field preferred
  • Minimum of one year of experience in Quality Assurance and Quality Control within an FDA-regulated industry.
  • Proficient in delivering customer service to both internal and external clients, adhering to service quality standards, and assessing customer satisfaction.
  • Skilled in managing and coordinating multiple tasks simultaneously, handling competing priorities, and meeting critical deadlines.
  • Proficiency in using Microsoft Office Suite.


RESPONSIBILITIES:

  • Generate trending reports on complaints and initiate requests for corrective actions.
  • Update complaints in the SAP Complaint System, ensuring accurate logging and closure.
  • Conduct investigations into product complaints using methods such as sample performance testing, image evaluation, historical data analysis, and other techniques. Recommend product improvements based on these investigations.
  • Draft summary letters regarding complaint investigations to the individuals who reported the issues.
  • Issue credits, coordinate servicing, replacement orders, and/or Return Goods Authorizations (RGAs) as necessary for resolving complaints.
  • Follow up with the sales force regarding outstanding issues within the time frames specified in written procedures.
  • Coordinate and monitor rework/stock checks of products as needed in response to complaints.
  • Ensure compliance with Quality System Regulation (QST), ISO regulations, and policies and procedures.


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