Senior Complaint Investigator

  • location: Pittsburgh, PA
  • type: Contract
  • salary: $25 - $30 per hour
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job description

Senior Complaint Investigator

job summary:
Great client looking for a 3-4 month contractor to work as a compliant investigator.

 
location: Pittsburgh, Pennsylvania
job type: Contract
salary: $25 - 30 per hour
work hours: 9am to 5pm
education: Bachelors
 
responsibilities:
  • Ensures compliance with all appropriate laws and regulations, relevant to the job function.
  • Supports the implementation of policies and procedures to ensure compliance with appropriate statutes and regulations.
  • Supports the complaint management process through:

    • Monitoring quality, completeness and timeliness of complaint investigations.
    • Determining the root cause of reported complaints using adequate methodology for complaint investigation.
  • Analyzes data and draws conclusions based upon the available information from the investigation and documents findings (including medical investigations) in complaint reports.
  • Performs data analysis and trending of filed complaint data to identify improvement opportunities and secure resources to drive continuous improvement across the organization.
  • Supports Post Market Surveillance (PMS) and Risk Management activities, by completing the above functions and providing summary reports of relevant activities.
  • Supports Health Hazard Evaluation for suspected adverse incidents.
  • Works closely with medical advisor(s) and medical investigation team to quantify risk. Requirements
 
qualifications:
  • High School education plus advanced technical training and experience or equivalent required.
  • Licenses/Certifications Experience Competencies Thorough knowledge of regulatory compliance requirements (e.g., GMP, 21 CFR 820, ISO 13485) as well as quality assurance principles and practices.
  • Knowledge of general statistics and statistical sampling preferred.
  • Seasoned professional with ability to influence at all levels of an organization; excellent negotiation skills
  • Ability to work with a diverse network of both internal and external groups and/or individuals.
  • Highly flexible and adaptable; ability to shift focus and drive change throughout the organization
  • Ability to interpret diverse regulations and drive/influence effective implementation.
  • Experience in statistical sampling techniques and working with test equipment required.
 
skills:
  • quality, regulations, equipment inspection, compliant investigations
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Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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