What are the responsibilities and job description for the Complaint Investigator position at Pyramid Consulting, Inc?
Job ID: 25-63351
Pay Range: $26 - $28/hour. Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location).
Key Responsibilities:
- Manual intake of complaints from functional mailbox account to SFDC complaint creation.
- Monitoring of list views for intake of automated complaints created.
- Manual movement of complaints from open to evaluation state incase stuck in open state for more than 24 hours from date created (or as otherwise instructed by Leadership / internal SOPs)
- Perform good faith efforts (GFE), as applicable.
- Complaint determination
- Duplicate check
- Complaint split, as applicable.
- Medical device reporting determination; escalation to Vigilance Specialist, if applicable.
- Review of keywords for patient harm
- Assignment of reported problem code, resolution codes, hazards, hazardous situations product naming conventions, UDI, etc., per local procedures
- Completed evaluation process as per timelines.
- Document investigation summary.
- Peer review activity for evaluation work
- Product return determination
- Document investigation summary.
- Assist with customer response letters, as needed.
- Complaints closure.
- Keep abreast of changes in the process.
- Complete all needed records in a timely and accurate manner.
- Adherence to schedules, work plans, and performance requirements.
- To meet service level expectations and maintaining high quality delivery.
- Has clear understanding of KPIs.
Key Requirements and Technology Experience:
- Key skills; Compliant Investigation , CAPA , CFR Parts 803/806/820, ISO 13485, Medical Narratives, Complaint Handling, Medical Device Reporting, Coding (Problem, Resolution, UDI).
- Basic understanding of CAPA, as well as global medical device regulations, requirements, and standards such as 21 CFR Parts 803, 806, and 820, and ISO13485.
- Able to write effective Medical and Technical narratives regarding the complaints.
- Must have good computer skills.
- Able to think critically and ask pertinent questions to gather necessary information.
- Good problem solving and analytical skills.
- Attention to detail.
- Works autonomously within established procedures and practices to meet complaint timeline requirements.
Our client is a leading IT Industry, and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration.
Pyramid Consulting, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
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Salary : $26 - $28
