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Product Investigation Specialist
Product Investigation SpecialistInsight Global • Jacksonville, FL, United States
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Product Investigation Specialist

Product Investigation Specialist

Insight Global • Jacksonville, FL, United States
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Job description :

One of our large clients in the medical device industry is seeking a Product Complaint Investigator to join their team here in Jacksonville. This person will be responsible for :

Responsibilities :

  • Evaluate and investigate customer complaints related to Johnson & Johnson product quality issues and concerns.
  • Review Device History Records (DHRs) and document findings in the Complaint Handling System (CHS).
  • Review complaint investigation results, ensuring compliance with regulatory requirements.
  • Perform product receiving and testing, documents result in a timely manner per applicable procedures.
  • Determine if further investigation activities are needed based on investigation results including Failure investigations
  • Collaborate with technical teams, subject matter authorities, medical safety team, and manufacturing sites to ensure effective data analysis, and closure of investigations.
  • Coordinating equipment repairs, maintenance, and calibration activities, ensuring operational excellence across the organization with the appropriate teams.

This position pays between $17-20 / hour.

Required Skills & Experience :

  • University / Bachelor’s Degree or Equivalent
  • 0 to 2 years of relevant work experience
  • Nice to Have Skills & Experience :

  • Experience with GxP (GMP, GLP and GDP) guidelines, policies, and procedures.
  • Knowledge of effective investigation methodologies for complaints, NC / CAPA, and laboratory issues.
  • Computer Skills Optional : Power BI, Envision Quality (EtQ), Agile, Sharepoint
  • Basic knowledge of applicable US & non-US applicable regulations and standards (For example 21 CFR 820, ISO13485, European Medical Device Directive).
  • Experience with equipment calibration and preventive maintenance activities.
  • Job Type : Contract

    Benefits :

  • Dental insurance
  • Health insurance
  • Vision insurance
  • Work Location : In person

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    Product Specialist • Jacksonville, FL, United States