Gangatharan K

• Built and maintained Power BI dashboards tracking complaint trends, regional KPIs, and quality performance metrics across EMEA enabling data-driven decision-making for senior stakeholders.
• Automated complaint-handling workflows using Power Automate (Cloud and Desktop), reducing manual effort by streamlining data capture, routing, and reporting within a regulated QMS environment.
• Conducted systematic data gap analysis across cross-system datasets (ServiceMax and TrackWise), identifying inconsistencies and coordinating remediation — improving data integrity and audit readiness.
• Queried and reconciled complaint records across multiple databases to maintain bidirectional traceability, ensuring complete audit trails and consistent data across systems.
• Applied statistical risk evaluation (ISO 14971) during complaint investigations — assessing severity and probability of failure modes and translating findings into structured investigation reports.
• Collaborated cross-functionally with field service, engineering, and regulatory teams to translate raw complaint data into actionable quality insights and corrective actions.
• Supported audit readiness by authoring procedural documentation and quality management records aligned with ISO 13485, FDA 21 CFR Part 820, and EU MDR 2017/745.

Product Development and Technical Analysis

• Developed API programs using Creo ProToolKit for client-specific applications.
• Analyzed and troubleshot design data using the Creo user interface for data mapping and process optimization.
• Created conceptual designs for SPM (Special Purpose Machine) using Creo 3D modeling software.
• Presented technical concepts and work processes to clients, ensuring alignment with requirements.
• Developed products with accurate cost analysis and material specifications.
• 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.