The medical device industry is one of the most strictly regulated sectors in the world. When a piece of healthcare technology—ranging from a simple thermometer to a complex MRI machine—doesn’t perform as expected, a specialized team of investigators steps in.
Wipro, a global leader in technology and business process services, is currently hiring experienced professionals for its Medical Device Complaint Investigation team in Pune. This is an exciting opportunity for life science graduates with 3–6 years of experience to work at the intersection of healthcare, regulatory science, and engineering. 🚀
What is Medical Device Complaint Investigation? 🔍
In MedTech, a “complaint” is not just customer dissatisfaction—it is a critical regulatory event.
A complaint includes any written, electronic, or verbal communication alleging deficiencies in:
- Identity
- Quality
- Durability
- Reliability
- Safety
- Effectiveness
- Performance
Once a device is released to the market, every complaint becomes part of Post-Market Surveillance (PMS) obligations.
As an investigator, your responsibilities include:
🛠️ Root Cause Analysis (RCA)
- Identify whether the issue stems from manufacturing defects, design flaws, software glitches, labeling issues, or use error.
- Collaborate with engineering and quality teams.
- Initiate CAPA (Corrective and Preventive Actions) where required.
⚠️ Risk Assessment
- Evaluate patient safety impact.
- Determine device risk classification.
- Assess reportability thresholds.
📑 Regulatory Reporting
- Ensure compliance with global standards like:
- ISO 13485
- EU MDR
- FDA Medical Device Reporting (MDR)
- Maintain accurate documentation for audits and inspections.
You are essentially a medical detective ensuring that unsafe products never compromise patient lives.
Key Requirements: Are You the Right Fit? ✅
Wipro is looking for professionals who combine technical knowledge with investigative thinking.
🎓 Educational Background
- Life Science Graduate (B.Sc, M.Sc, B.Pharm, etc.)
- Strong understanding of medical terminology and biological systems.
💼 Experience
- 3–6 years in:
- Medical device complaint handling
- Quality Management Systems (QMS)
- Post-Market Surveillance
📜 Regulatory Expertise
You must have working knowledge of:
- ISO 13485
- EU MDR
- PMS requirements
- Risk classification and reporting timelines
🗣️ Communication Skills
- Strong written and spoken English.
- Ability to prepare documentation reviewed by authorities like:
- U.S. Food and Drug Administration
- European Medicines Agency
🏢 Work Setup
- Work-from-office role in Pune.
- Rotational shifts.
- Immediate joiners preferred.
Why Pune is the Place to Be 🌆
Pune has emerged as a major hub for HealthTech and IT services.
🌐 Professional Growth
- Thriving IT parks like Hinjewadi.
- Expanding MedTech ecosystem.
- Strong professional networking opportunities.
🌄 Lifestyle Benefits
- Pleasant climate.
- Proximity to the Western Ghats.
- Vibrant food and cultural scene.
📈 The Wipro Advantage
- Fortune 500-level exposure.
- Global client base.
- Structured career growth.
- Learning & certification support.
The Importance of EU MDR & ISO 13485 in 2026 📜
The EU MDR (European Union Medical Device Regulation) has significantly increased compliance requirements.
Today, investigators must:
- Understand device classification (Class I, IIa, IIb, III).
- Identify reportable events within strict timelines.
- Support proactive Post-Market Surveillance systems.
- Contribute to risk management files.
Professionals who master EU MDR and ISO 13485 are among the most in-demand regulatory specialists globally.
Life in Rotational Shifts: What to Expect 🕒
Because Wipro serves global clients, 24/7 coverage is essential.
Benefits May Include:
- 💰 Shift allowances
- 🚗 Reduced peak-hour traffic
- 🏦 Flexibility for personal errands
It demands adaptability—but also offers financial and lifestyle advantages.
How to Apply and Stand Out 📝
📧 Send your updated resume to: merlin.michael@wipro.com
Resume Optimization Tips:
✔ Include keywords:
- ISO 13485
- EU MDR
- Root Cause Analysis
- CAPA
- Post-Market Surveillance
✔ Quantify your experience:
“Investigated 50+ high-priority complaints monthly with 100% EU MDR timeline compliance.”
✔ Professional Subject Line:
Application for Medical Device Investigation – [Your Name] – [Years of Experience]
Final Thoughts 🌟
A career in Medical Device Complaint Investigation is more than a job—it’s a responsibility toward global patient safety.
Every investigation you complete helps:
- Prevent device recalls
- Protect patients
- Strengthen healthcare systems
If you have the expertise and the drive, this opportunity at Wipro Pune could be your next big career move.
