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Complaint Investigator II

Ascent Services Group

Job Description

Complaint Investigator II
Pittsburgh, PA
Contract: 3+ months

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.
    • Write complaint reports in applicable manner for the customers.
  • 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 Education
  • 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.
Other
  • 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.
  • Excellent interpersonal & communication skills, both written and verbal.
  • 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.
  • Must be able to read specifications and are familiar with inspecting equipment.
  • Requires excellent verbal and written communication skills and the ability to work with minimal supervision.

Job Requirements

 
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Job Snapshot

Location US-PA-Pittsburgh
Employment Type Contractor
Pay Type Hour
Pay Rate $0.00 - $30.35 /Hour
Store Type Other

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Terms & Conditions
Snapshot
Ascent Services Group
Company:
US-PA-Pittsburgh
Location:
Contractor
Employment Type:
Hour
Pay Type:
$0.00 - $30.35 /Hour
Pay Rate:
Other
Store Type:

Job Description

Complaint Investigator II
Pittsburgh, PA
Contract: 3+ months

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.
    • Write complaint reports in applicable manner for the customers.
  • 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 Education
  • 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.
Other
  • 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.
  • Excellent interpersonal & communication skills, both written and verbal.
  • 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.
  • Must be able to read specifications and are familiar with inspecting equipment.
  • Requires excellent verbal and written communication skills and the ability to work with minimal supervision.

Job Requirements

 
Complaint Investigator II Apply now