A leading medical device organization is conducting a walk-in interview for Medical Device Complaint Investigator roles in Kolkata. This opportunity is ideal for freshers and experienced professionals (0–5 years) with hands-on exposure to medical device complaint investigation, risk management, and CAPA. Immediate joiners willing to work from office and relocate to Kolkata are strongly preferred.
If you are building a career in medical device vigilance, complaint handling, and regulatory compliance, this walk-in interview on 9 January 2026 could be the right next step.
📍 Walk-In Interview Details
- Job Title: Medical Device Complaint Investigator
- Job Location: Kolkata (Work from Office)
- Interview Date: 9 January 2026
- Reporting Time: 10:00 AM – 12:30 PM
- Interview Mode: Walk-In
Venue:
Gate 1, Plot No. 8 & 9, Block DM,
Sector V, Salt Lake,
Kolkata, West Bengal – 700091
Contact Person: Sarita
🧪 Key Responsibilities
Perform Medical Device Complaint Investigation in accordance with ISO 13485 and ISO 14971 requirements
Conduct risk assessment activities including FMEA (Failure Modes and Effects Analysis) for reported complaints
Evaluate complaint data to identify potential product quality, safety, and compliance risks
Perform root cause analysis and support implementation of CAPA actions
Ensure accurate documentation and timely closure of complaints within defined SLAs
Support post-market surveillance (PMS) and vigilance-related activities
Collaborate with cross-functional global teams including Quality, Regulatory Affairs, and Engineering
Ensure compliance with internal SOPs, global quality systems, and regulatory expectations for medical devices
🎓 Eligibility & Qualifications
Education (Any one):
- B.Pharm / M.Pharm
- Biomedical Engineering / Mechanical Engineering
- B.Sc in Medical Imaging & Radiology Technology
- Master’s in Molecular Biology
- B.Sc Nursing
- BDS
Experience:
- 0 to 5 years
- Prior experience in medical device complaint investigation is mandatory
🛠️ Skills Required
- Strong knowledge of Medical Device Risk Management, CAPA, and Complaint Handling
- Excellent English communication (written and verbal)
- Willingness to work in rotational shifts
- Ready to relocate to Kolkata
- Ability to work in a regulated, process-driven environment
💼 Salary & Benefits
- Estimated Salary: ₹4,00,000 – ₹7,50,000 per annum (CTC)
- Exposure to global medical device quality systems
- Strong learning curve in device vigilance & investigations
- Stable work environment with compliance-focused culture
📝 How to Apply (Walk-In Instructions)
Candidates must attend the walk-in interview in person with the following:
- Updated CV (Mandatory)
- Original Government ID Card
- Important: Mention the source “Mandeep Sharma” at the top of your CV
Immediate joiners will be given preference.
INTERVIEW QUESTIONS
Tell me about yourself.
Why are you interested in a Medical Device Complaint Investigator role?
What do you understand about complaint handling in medical devices?
Why Wipro?
Are you comfortable with rotational shifts and work-from-office?
Can you relocate to Pune?
What is a medical device complaint?
Difference between a complaint and a service request?
What are the key steps in the complaint investigation lifecycle?
What information is required to initiate a complaint investigation?
What is complaint triage?
When is an investigation mandatory vs not required?
What is complaint closure and what are the criteria?
Expected concepts to mention:
- Complaint intake → triage → investigation → risk assessment → CAPA (if required) → closure → documentation
What is risk management in medical devices?
Explain ISO 14971.
What is hazard, hazardous situation, and harm?
What is FMEA?
How do you assess severity, occurrence, and detectability?
How do complaints impact the risk management file?
What is CAPA?
Difference between Corrective Action and Preventive Action?
When do we raise a CAPA from a complaint?
What are common root cause analysis tools?
- 5 Whys
- Fishbone (Ishikawa)
Who is responsible for CAPA ownership?
- What is ISO 13485?
- Why is ISO 13485 important for medical devices?
- How does complaint handling fit into QMS?
- What documents are controlled under QMS?
- What is document control?
They do not expect deep regulatory expertise, but awareness is essential.
- What is post-market surveillance?
- What is vigilance reporting?
- Difference between complaint handling and adverse event reporting?
- What is an MDR report (basic understanding)?
- What happens if a complaint indicates a serious injury or death?
A customer reports device malfunction but no patient harm. What will you do?
A complaint is received with incomplete information. How do you proceed?
During investigation, you identify a recurring issue. What is your next step?
What would you do if Engineering disagrees with your investigation conclusion?
What is complaint trending?
Why is trending important?
What KPIs are monitored in complaint handling?
Importance of audit readiness?
How do you ensure data integrity in investigations?
Have you worked with any QMS or complaint management systems?
Are you aware of tools like TrackWise, Argus (for safety), or custom QMS tools?
How do you ensure accuracy while documenting investigations?
How do you handle tight timelines?
How do you ensure quality under pressure?
Describe a situation where you identified a quality risk.
How do you handle repetitive work without errors?
What is a medical device?
Difference between drug and medical device?
What motivated you to choose this field?
Are you willing to learn regulatory guidelines?
How many complaints have you handled end-to-end?
Have you supported audits or inspections?
How do you handle escalations?
Experience with CAPA closure?
How do you train junior team members?
