Valued Team member: We are glad you are exploring current opportunities within Zimmer Biomet

What You Can Expect

The Systems Engineer – Complaint & Event Investigation is responsible for conducting rigorous, compliant investigations of product complaints, nonconformances, and adverse events to determine root cause, assess device and patient impact, and support regulatory decision-making. This role plays a critical role in post-market surveillance, MDR assessment, risk management linkage, and inspection readiness.
The position partners closely with Quality, Regulatory Affairs, Manufacturing, R&D;, and Clinical teams and is especially suited to complex electromechanical or robotic medical devices.

Work Location: Bangalore
Work Mode: Hybrid (3 Days in office)
Shift Timing - 11:00 AM - 8:00 PM

How You'll Create Impact

Complaint & Event Investigation
• Conduct thorough investigations of complaints, nonconformances, and adverse events
• Determine root cause, contributing factors, and device performance impact
• Evaluate investigation data including complaint records, service data,



manufacturing history, and design documentation
• Ensure investigations are completed accurately, thoroughly, and within required timelines
FDA Regulatory Compliance
• Perform investigations in accordance with 21 CFR Part 820 (Quality System Regulation)
• Support 21 CFR Part 803 (Medical Device Reporting – MDR) reportability assessments
• Provide investigation outputs that support regulatory submissions and health authority inquiries
• Ensure documentation meets FDA and internal quality expectations
Risk & Patient Safety Evaluation
• Assess patient safety, clinical risk, and device performance impact of reported events
• Link investigation outcomes to risk management activities per ISO 14971
• Support updates to risk files, hazard analyses, and risk controls based on post-market findings
Cross-Functional Coordination
• Collaborate with Quality, Regulatory Affairs, Manufacturing, R&D;, Clinical, a

📌 System Engineer (Bengaluru)
🏢 ZB Global Services India
📍 Bengaluru