What are the responsibilities and job description for the Complaint Investigator position at Tanisha Systems, Inc?
Complaint Investigator
Contract
Atlanta, GA 30341. – 5 Day onsite
Job description
PRINCIPAL 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.
SKILLS REQUIRED:
- 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.
CANDIDATE SPECIFICATIONS:
- Bachelor’s degree or Diploma in bio medical engineering, Pharma, Science, or related technical degree with 2-5 years of experience; OR: Bachelor’s degree or Diploma with 2 years of experience in a medical device or regulated industry.
- Medical Device or biomedical experience in undergraduate program or other related work experience preferred.
