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Sheetal Shivaji Dudhade

@sheetalshivajidudhad

Quality Engineer at Stryker handling Acute Care and Emergency Care product complaints and standardizing complaint documentation.

India

Message

What I'm looking for

I’m targeting impactful roles in the Healthcare and Medical Devices sectors within Pune, where ambition and operational excellence are prioritized.

At Stryker, I handle complaints for Acute Care and Emergency Care products, working with Field Service Engineers, Manufacturing, and R&D as needed. I led a complaint review initiative to improve consistency and standardization in team documentation, and assisted in developing internal escalation guidelines.

Previously, as a Quality Control Engineer at Incredible AM Pvt Ltd., I inspected products across their lifecycle and supported compliance with ISO 13485 and ISO 9001. I also delivered cross-functional training on failure modes and led an initiative to build understanding of post-processing processes and their limitations.

Experience

Work history, roles, and key accomplishments

Current

Quality Engineer

Current

Stryker

Apr 2024 - Present (2 years 6 months)

Handles complaints on Acute Care and Emergency Care products, ensuring audit readiness via internal policies. Coordinates with cross-functional teams to investigate root causes and maintain transparency with stakeholders.

Complaint Handling Trackwise Salesforce MasterControl Root Cause Analysis CAPA ISO 13485 MDSAP Quality Documentation Stakeholder Management

Quality Control Engineer

Incredible AM Pvt Ltd.

Feb 2022 - Apr 2024 (2 years 2 months)

Conducted material testing, product inspection, and quality planning across the product lifecycle. Ensured regulatory compliance with ISO 13485 and ISO 9001 and prepared quality reports for management.