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
- 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
- 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.
- quality, regulations, equipment inspection, compliant investigations
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.