Website Tanisha Systems
Tanisha Systems
Company : Tanisha Systems
Location: Atlanta, GA 30341- Onsite
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.