Tushar Yadav
QA-Executive
Palwal
Summary
Results-driven Mechanical Engineer with over 6 years of progressive experience in Production, Quality Control, Tooling, and Validation within the Automotive and Medical Device industries. Proven track record in managing production planning, sub-assemblies, die-casting, and vehicle assembly, with hands-on expertise in AutoCAD, UG NX, GD&T, 7QC tools, Kaizen, and CAPA methodologies. Strong background in Change Control management, risk assessment, and validation documentation aligned with project timelines.
Demonstrated ability to lead cross-functional teams, drive process improvements, and ensure compliance with ISO 13485, FDA 21 CFR Part 820, and other international regulatory standards. Adept at supplier quality management, internal and external audits, and QMS enhancements. Experienced in software validation, including AI algorithm documentation per FDA/CE/MDR guidelines. Skilled in coordinating between R&D, manufacturing, toolmakers, and regulatory teams to ensure end-to-end product quality and lifecycle traceability.
Overview
7
7
years of professional experience
4
4
Certifications
2
2
Languages
Work History
QA Executive
Polybond India Private Limited
Pune
03.2025 - Current
- Incoming Quality Inspection: Check and verify raw materials and components for compliance with quality standards.
- In-Process Inspection (Injection Molding): Monitor molding processes to ensure product quality during production.
- Final Testing: Conduct functional and visual checks on finished products before shipment.
- Process Validation: Support validation activities (IQ/OQ/PQ) to ensure molding processes meet regulatory and quality requirements.
- Documentation & Compliance: Maintain accurate records in line with medical device quality standards (e.g., ISO 13485).
- Troubleshooting: Identify and resolve molding process issues to minimize defects.
- Collaboration: Work with QA, production, and engineering teams to improve quality and efficiency.
Senior Engineer
Polymedicure Limited
Faridabad
11.2022 - 03.2025
- Utilized systematic problem-solving methodologies (5Why, DMAIC, 8D) to identify, prioritize, communicate, and resolve quality issues.
- Validation testing ( Installation Qualification IQ, Operational Qualification OQ, Performance Qualification PQ.
- Maintained quality standards by effectively managing relationships with suppliers.
- Handled and resolved customer complaints, ensuring high levels of satisfaction and retention.
- Initiated and oversaw the Change Control submission and review processes, conducted Risk Assessments, and obtained Validation Plan approvals based on product functional use or testing.
- Compiled tooling and meticulously maintained molding-related documentation in strict accordance to regulatory requirements, ensuring compliance and high-quality standards for Medical devices.
- Executed the Production Part Approval Process for components and designs, ensuring adherence to quality standards.
- Actively participated in cross-functional meetings for the development of new products and modifications to existing components, aligning with customer requirements and business goals.
- Reviewed manufacturing processes, identified quality problems, provided technical assistance, and reported supplier performance to senior management, resulting in continuous improvement initiatives.
- Assisted vendors in improving their performance and capabilities related to design, product development, costing, quality, and logistics.
- Leveraged expertise as a 'First Parts Approval Expert' to ensure precision and quality in production processes.
- Ensured injection molding parameters were within prescribed ranges, optimizing quality and efficiency.
- Compiled tooling and molding documentation in accordance with regulatory standards, ensuring accuracy and compliance.
Engineer
MAHINDRA DEFENCE SYSTEMS
Faridabad
02.2020 - 11.2022
- Perform quality gate checks before starting the assembly.
- Dealing with supplier.
- Responsible for quality assurance and quality control at different stages using a problem-solving approach and why-why analysis.
- Resolve problems during operation.
- Check and ensure equipment is within calibration date and functioning properly.
- Update daily 5S and safety condition of the workstation.
- Facility identification, planning and monitoring.
- Providing assistance in the assembly and maintenance of engineering and other technical files.
- Inspection of various items of Ongoing Project.
- Preparation of quality assurance plan & machinery parts etc. As per Client requirements.
- Distribution of work to subordinates according to their capability, preparation of different types of documents.
- Maintain and prepare DPR.
- Coordinate with store and purchase department for materials according to BOM.
Graduate Executive Trainee
Pooja Metal Processors
Faridabad
09.2018 - 01.2019
- Maintain quality on the shop floor and maintain hourly inspection reports.
- Check all the tools and devices working properly as per instruction.
- Distribution of work to subordinates according to their capability, preparation of different types of documents regarding inspection & dealing with 3rd party’s inspector.
- To Dispatch material which is cleared from TPI or Client End.
- Production planning as per customer requirement.
Education
Bachelor Of Technology - Mechanical Engineering
Rawal Institution
Faridabad 08.2018
Skills
Internal & External Audit
- AutoCAD
- UG NX
- Kaizen
- CAPA (Corrective and Preventive Actions)
- PDI (Pre-Delivery Inspection)
- Die-Casting Processes
- Sub-Assemblies & Vehicle Assembly
- Production Planning & Control
- Quality Control & Assurance
- Manufacturing Process Optimization
- In-Process Inspection
- Tooling & Molding Documentation
- Validation
Quality & Regulatory Compliance
- ISO 13485 Compliance
- FDA 21 CFR Part 820 Compliance
- CE/MDR Documentation
- Quality Management System (QMS)
- Risk Assessment & Management
- Validation Planning & Protocols
- Design Control, Verification & Validation
- Change Control & Document Control
- SOP, NCR Review
- Supplier Quality Management
- Vendor Qualification & Audits
- Internal & External Audit Support
Soft Skills & Management
- Cross-Functional Team Collaboration
- Team Leadership & Coordination
- Project & Timeline Management
- Problem Solving & Root Cause Analysis
- Effective Communication
- Continuous Improvement Mindset
- Regulatory & Customer Interface
Functional testing
Performance testing
Certification
Executive Engineer - Lead a team in PFFR (Pokhran Field Firing Range)
Social Link
https://www.linkedin.com/in/tusharyadav-t4747
Total Work Experience
6 Years
Timeline
QA Executive
Polybond India Private Limited
03.2025 - Current
Senior Engineer
Polymedicure Limited
11.2022 - 03.2025
Engineer
MAHINDRA DEFENCE SYSTEMS
02.2020 - 11.2022
Graduate Executive Trainee
Pooja Metal Processors
09.2018 - 01.2019
Bachelor Of Technology - Mechanical Engineering
Rawal Institution
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