Product Incident Report Technician

Shift: 1st Shift (8:00 AM - 4:30 PM)

Location: Onsite

Travel: Occasional travel to affiliate facilities

Department: Quality / PostMarket Surveillance

Pay rate: $21/hr.

The Product Incident Report Technician is responsible for processing, evaluating, and documenting customer complaints related to medical products. This role is critical to patient safety and product quality, as complaint investigations often uncover systemic issues that may require corrective action or, in rare cases, product recalls.

The technician performs complaint intake, conducts product testing and evaluations, collaborates with crossfunctional teams, and ensures all documentation meets regulatory and internal quality system requirements. This position requires strong writing skills, comfort working with returned medical devices-including contaminated samples-and the ability to manage a high volume of cases with accuracy and urgency.

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  Document customer complaints and Product Incident Reports (PIRs) received from Customer Service or directly from customers.

  
  
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  Perform initial complaint evaluations, including PIR history review, manufacturing record review, and assessment of complaint criticality.

  
  
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  Conduct product investigations, including:

  
  
  
  
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    Testing and evaluating returned samples

    
    
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    Verifying reported issues

    
    
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    Performing contamination testing when required

    
    
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    Requesting root cause analysis from internal or external partners

    
    
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    Documenting all findings clearly and accurately

    
    
  
  
  
  
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  Review corrective action responses to ensure root causes are addressed effectively.

  
  
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  Generate trend data for assigned facilities, vendors, or product lines.

  
  
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  Finalize, close, and file complaint reports in accordance with quality system requirements.

  
  
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  Follow up with responsible teams to ensure corrective actions remain effective.

  
  
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  Communicate findings with MRB teams, engineering, suppliers, and affiliate locations.

  
  
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  Maintain compliance with FDA Quality System Regulations and internal complainthandling procedures.

  
  

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  Support continuous improvement initiatives related to complaint handling and product quality.

  
  
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  Assist affiliate facilities with complainthandling processes when needed.

  
  
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  Perform other duties as assigned by management.

  
  

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  High School Diploma or GED.

  
  
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  Strong written communication skills-this role requires extensive documentation and report writing.

  
  
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  Ability to perform handson product testing in a lab environment, including handling contaminated samples with appropriate PPE.

  
  
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  Organizational skills and the ability to manage multiple investigations simultaneously.

  
  
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  Proficiency with Microsoft Word and Excel, Document Management Systems, SAP, and database tools.

  
  
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  Ability to communicate effectively with internal teams, external customers, suppliers, and affiliate sites.

  
  

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  Associate degree in a technical field (Engineering Technician, Quality, etc.) or Bachelor's degree.

  
  
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  ASQ Certified Quality Technician (CQT).

  
  
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  Knowledge of FDA Quality System Regulations and complainthandling requirements.

  
  
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  Experience with inspection techniques, root cause analysis, and quality documentation.

  
  
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  Familiarity with contamination testing, product evaluation, or QCrelated testing.

  
  

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  Understanding of complainthandling regulations and quality system expectations.

  
  
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  Ability to operate lab equipment and perform product testing.

  
  
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  Strong problemsolving skills and the ability to work independently.

  
  
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  Ability to manage deadlines, trend data, and high complaint volumes (3,800+ annually).

  
  
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  Excellent verbal and written communication skills in English.

  
  

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  Regularly required to sit, talk, and hear.

  
  
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  Frequently required to use hands to handle or feel, and reach with hands and arms.

  
  
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  Occasionally required to stand, walk, and lift/move up to 30 lbs.

  
  
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  Must be able to safely handle returned medical products, including those with biological contamination, using provided PPE.

  
  

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  Work performed in both office and laboratory settings.

  
  
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  Moderate noise levels.

  
  
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  Potential exposure to biohazard conditions, chemicals, and solvents.

  
  
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  PPE provided and required for all contaminationrelated testing.

  
  

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