QA/RA Complaint Specialist

Dukal Corporation – Ronkonkoma, NY

  • On a daily basis, reviews and processes assigned complaint records related to product quality and patient safety.
  • Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
  • Gather, compiling and analyzing complaint trend data and escalate issues related to customer complaint trends and non-conforming product.
  • Participates in complaint review board meetings.
  • Collaborate with internal and external resources to research and validate defect and identify root cause
  • Document investigation including research, analysis, findings, and status updates in Quality systems.
  • Ensures complaint files are investigated, complete and closed in a timely manner per Dukal Customer Compliant procedure.
  • Communicate with the US and International office and/or other sources for resolution of root cause
  • Interact with customers verbally or in writing using clear, effective communication. This may involve translating technical language into more common terms easily understood by customers.
  • Stay current on all Standard Operation Procedures that pertain to Customer Complaint management
  • Perform other quality assurance and quality control functions as necessary, with appropriate training
  • Job Type: Full-time

    Salary: $50,000.00 to $60,000.00 /year


  • Medical Devices: 3 years (Preferred)
  • ISO 13485: 3 years (Preferred)
  • writing SOP s: 3 years (Preferred)
  • Processing Customer Complaints: 2 years (Preferred)
  • Quality Assurance: 3 years (Preferred)
  • Education:

  • Bachelor s (Required)
  • Work authorization:

  • United States (Required)
  • This job posting is no longer available on OPTnation.
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