Omkar Tatale
Gurgaon
Summary
Curiosity-driven Quality Engineer at Stryker with expertise in root-cause analysis and continuous improvement. Authored 40+ product safety reports and led efficiency projects, saving 400 hours annually. Demonstrated critical thinking and technical writing skills while enhancing compliance and safety through data analysis and process automation initiatives.
Overview
3
3
Languages
1
1
Certification
4
4
years of professional experience
Work History
Quality Engineer
Stryker
Gurgaon
07.2023 - Current
- Authored 40+ product safety reports, including PSURs and PMSRs, ensuring compliance with regulatory standards.
- Supported regional RAQAs for drafting safety reports as per country-specific requirements: 50+ China PRERs and 4 TGA reports.
- Updated QMS procedure in accordance with product safety reporting global requirements, with internal stakeholders.
- Analyzed quality metrics and PMS data to identify trends and areas of improvement.
- Performed data analysis to identify root causes of quality issues, and developed corrective actions.
- Implemented process improvements based on Lean Six Sigma methodologies, resulting in reduced waste and increased efficiency.
- Facilitated continuous improvement projects focused on reducing waste, and increasing efficiency.
- Maintained up-to-date knowledge of industry quality standards, and regulatory requirements.
- Led multiple cost-of-poor-quality projects, leveraging data analysis to drive resolution of identified issues.
- Developed a robust system to accurately calculate usage for the robotics products for the IMDRF rate calculations.
- Supported the team in four external and three internal audits.
- Successfully led a CAPA originated from MDSAP audit for Canadian requirements.
- Led four process efficiency projects with total savings of 400 hours per year.
- Established compliant PMS support process in NPD projects, successfully supporting 7 projects with plans for broader implementation across divisions.
- Acting in the capacity of project manager for the process automation project, with estimated savings of 600 hours per year.
- Working with Saudi Arabia and Egypt RAQA to complete gap analysis from the regional PMS requirement and current PSUR process.
- Leading a cross functional team to develop a strategy to address new requirements for China PRERs.
- Initiated and managed continuous improvement projects, utilising Six Sigma and Kaizen methodologies to drive quality enhancements and efficiency.
- Supported root cause investigations and CAPA activities by analyzing quality and post-market data, identifying systemic issues, and implementing sustainable corrective actions.
Intern
Stryker
Gurgaon
08.2022 - 07.2023
- Investigated over 600 robotics product complaints, ensuring accurate evaluation, documentation, and resolution in compliance with regulatory requirements.
- Identified a new hazard for robotics devices by analyzing complaint data over five years, leading to updates in risk management files and FMEAs.
- Partnered with the Design Assurance team to update six product risk tables with the newly identified hazard, improving safety and compliance.
- Analyzed problems with the quality of products and worked with teams to develop solutions.
- Applied concepts learned in complaints handling to enhance practical work situations.
- Built and maintained strong cross-functional partnerships to enhance collaboration, decision-making, and project execution.
- Contributed to a positive team environment by collaborating with fellow interns on group projects and presentations.
- Managed multiple tasks simultaneously, honing organisational skills while meeting strict deadlines.
- Assisted staff members with daily tasks, enabling increased focus on higher-priority assignments.
Education
Bachelor's of Engineering - Mechanical Engineering
Maharashtra Institute of Technology College of Engineering
Pune, India11-2020
Master of Technology - Machine Design
National Institute of Technology Kurukshetra
Kurukshetra, India07-2023
Skills
- CAPA management
- Regulatory compliance
- FMEA
- Root cause analysis
- Data analysis
- Safety reporting
- Audit support
- Technical writing
- SOP development
- Six sigma methodologies
- Continuous improvement
- Complex problem solving
- Innovative thinking
- Risk management
- Process improvement
Certification
- MDR Expert Program level 3, 2025-11-01
- Internal Auditing for QMS for Medical Devices based on ISO 13485:2016, 2024-07-01
- LSS Yellow Belt, 2024-07-01
Accomplishments
- Finalist of rookie of the year award 2024.
- Conducted organization wide mental health awareness session.
- Received 4 Stryker superstar awards for delivering key project.
- Honored with 7 SHINE awards for exceptional performance.
Languages
English
Proficient
C2
Marathi
Proficient
C2
Hindi
Proficient
C2
Hobbies and interests
- Photography
- Travel & Exploration
- Poetry
- Community Engagement
Timeline
Quality Engineer
Stryker
07.2023 - Current
Intern
Stryker
08.2022 - 07.2023
Bachelor's of Engineering - Mechanical Engineering
Maharashtra Institute of Technology College of Engineering
Master of Technology - Machine Design
National Institute of Technology Kurukshetra