What are the responsibilities and job description for the Complaint Investigator - Medical Devices position at Wipro?
Job description
We are continuing to grow and expand! Come and join our team!
Wipro is seeking individuals who combine excellent medical device complaint investigation and problem-solving skills with the ability to function effectively both as part of a team or on an individual basis to bring their talent to our team.
Wipro is a leading, publicly traded, global IT solutions and services company with over 230,000 dedicated employees serving clients across multiple continents with over 130 locations in more than 65 countries.
We offer a strong compensation package that includes competitive hourly pay and day one benefits. Wipro also offers many opportunities for career advancement within our engaging and exciting culture.
PRINCIPAL RESPONSIBILITIES:
Do you know the the 3 classifications of Medical Devices? And, have you handled the entire medical device complaints process from start to closure -(Intake, evaluate, investigate, regulatory reporting and closure)?
If so, we are seeking your skills and talent on our complaint investigation team in Atlanta, GA.
We use Salesforce & Trackwise, SAP and Webtracker to process complaints, investigate them and report them to the US FDA or OUS.
Your day would include complaint determination, duplicate checks ,complaint splits, medical device reporting determination, and escalated as warranted to Vigilance Specialist
Review of keywords for patient harm, report problem code, resolution codes, hazards, hazardous situations product naming conventions, UDI, etc., per local procedures
Completed evaluation process as per timelines, document investigation summary. Completing all needed records in a timely and accurate manner. And adhere to schedules, work plans, and performance requirements.
SKILLS REQUIRED:
- CAPA experience
- Basic understanding of global medical device regulations, requirements, and standards
- 21 CFR Parts 803, 806, and 820
- ISO13485
- Able to write effective Medical and Technical narratives regarding the complaints.
- Able to think critically and ask pertinent questions to gather necessary information.
- Good problem solving and analytical skills.
- Bachelor’s degree
- Medical Device complaint investigator
- Pre-Screening Questions with answers
Job Type: Full-time
Pay: $25.00 per hour
Expected hours: 40 per week
Benefits:
- 401(k) matching
- Dental insurance
- Employee discount
- Flexible spending account
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Referral program
- Vision insurance
Schedule:
- 8 hour shift
Education:
- High school or equivalent (Required)
Experience:
- Complaint investigator for medical devices: 1 year (Required)
Ability to Commute:
- Atlanta, GA 30341 (Required)
Ability to Relocate:
- Atlanta, GA 30341: Relocate before starting work (Required)
Work Location: In person
Salary : $25
