Gangatharan Kannan

• Managed end-to-end complaint handling for medical instruments and reagents — including Infusion and Life Science products — across the EMEA region, ensuring full compliance with ISO 13485, FDA 21 CFR Part 820, and EU MDR 2017/745 throughout the complaint lifecycle.
• Evaluated reported product failures for MDR/ADE reportability, applying risk-based criteria to assess patient safety impact; coordinated timely submissions and documentation to regulatory bodies per applicable thresholds.
• Conducted thorough adverse event investigations using root cause analysis (5-Why, Fishbone) to identify failure modes, contributing to risk-informed corrective actions and preventing recurrence.
• Performed gap analysis on complaint records and cross-system data to identify missing technical information; coordinated with field service and clinical teams to ensure completeness of safety records.
• Maintained bidirectional data integrity between ServiceMax and TrackWise, ensuring full traceability of complaint and adverse event records across quality management systems.
• Designed Power BI dashboards tracking complaint trends, MDR/ADE KPIs, and regional performance metrics, enabling proactive identification of patient safety signals and data-driven corrective action prioritization.
• Automated complaint-handling and adverse event reporting workflows using Power Automate, reducing manual effort and improving process efficiency within a regulated quality management environment.
• Applied ISO 14971 risk assessment principles — hazard identification, risk estimation, and residual risk evaluation — during complaint and adverse event investigations to support risk-informed decision-making.
• Supported audit readiness by authoring and reviewing procedural documentation and quality management records aligned with regulatory standards for complaint handling and PMS activities.

Product Development and Technical Analysis

• Led end-to-end product design projects from concept approval through customer delivery, managing design reviews, verification activities, and stakeholder presentations.
• Designed various types of industrial automation and robotics machines, integrating multiple sub-assemblies into final assembly and general assembly drawings.
• Created dimensional drawings, main assembly drawings, and part drawings, along with the complete Bill of Materials (BOM) for entire robotic systems.
• Developed Operation & Maintenance manuals for all sub-assemblies within robotic machines.
• Developed CAD customization using Creo ProToolKit, applying structured design documentation and change management practices within the engineering product lifecycle.
• Recorded, transcribed, and distributed meeting minutes for project documentation.
• Managed the complete project lifecycle from design approval to customer site installation.

Key Achievements:

• Successfully delivered multiple SPM projects on time and within budget.
• Improved design efficiency through standardized processes and templates.

Quality Control and Process Improvement

• Led quality assurance initiatives that improved product compliance with regulatory standards, enhancing customer satisfaction and reducing defects
• Developed and implemented inspection protocols that streamlined quality control processes, resulting in increased efficiency by 25%, and reduced rework.
• Conducted incoming material inspection from suppliers using precision measurement equipment.
• Performed root cause analysis on product failures, implementing corrective actions that improved product reliability by 30%, and reduced warranty claims.
• Recommended and implemented strategies to improve overall product quality.
• Mentored junior engineers in quality management best practices, fostering a culture of continuous improvement.

Key Achievements:

• Reduced product defects by 35% through systematic inspection protocols.
• Decreased warranty claims by implementing effective corrective action plans.
• Improved supplier quality performance through rigorous inspection standards.

• Performed electrical system maintenance on transport buses, including wiring and circuit fault diagnosis, battery/starter motor/alternator servicing, and repair of lighting, indicator, and dashboard instrument systems.
• Carried out transmission system maintenance covering gearbox inspection and repair, clutch system servicing, and propeller shaft/differential work.
• Followed preventive maintenance schedules and checklists to ensure vehicle fitness and minimize breakdown occurrences.
• Attended to breakdown and emergency repairs, diagnosing faults and restoring vehicles to operational condition.
• Assisted senior mechanics in depot workshop operations, gaining hands-on exposure to standard maintenance procedures and repair workflows.