Compliant Investigator Medical Device Position Available In Fulton, Georgia
Tallo's Job Summary: The Compliant Investigator Medical Device role at Wipro Limited involves manual intake of complaints, monitoring list views, complaint determination, and medical device reporting. The position requires a basic understanding of CAPA and global medical device regulations, with skills in writing effective narratives and critical thinking. The ideal candidate holds a Bachelor's degree or Diploma in bio medical engineering, Pharma, Science, or related field, with at least 2 years of relevant experience in medical device complaint investigation.
Job Description
Wipro Limited (
NYSE:
WIT, BSE
507685,
NSE:
WIPRO) is a leading technology services and consulting company focused on building innovative solutions that address clients’ most complex digital transformation needs. Leveraging our holistic portfolio of capabilities in consulting, design, engineering, and operations, we help clients realize their boldest ambitions and build future-ready, sustainable businesses. With over 230,000 employees and business partners across 65 countries, we deliver on the promise of helping our customers, colleagues, and communities thrive in an ever-changing world. For additional information, visit us at www.wipro.com.
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 a minimum of 2 years of experience .
Medical Device complaint investigation from complaint intake to evaluation to investigation to regulatory reporting and closure work experience is a must.
