Shubham Mahajan
Phoenix,AZ
Summary
Manufacturing Quality Engineer graduated from the University of Michigan-Dearborn's Industrial and Systems Engineering program having competence in production floor maintenance, high volume manufacturing, supplier management, validation, new product introduction, problem solving and lean manufacturing. ASQ certified quality process analyst and green belt in lean six sigma, effective communicator at all organizational levels.
Overview
2
2
years of professional experience
1
1
Certification
Work History
Manufacturing Quality Engineer
Stryker
01.2022 - Current
- Conducted root cause analysis and implemented corrective and preventive actions (CAPA) to address non-conformances and quality issues, leading to improved product quality and customer satisfaction.
- Generated validation test protocols for facility, equipment, software, cleaning, test method, and process validation and executed equipment validation of (~150) equipment including (IQ, OQ, PQ) for assembly line transfer of 9 surgical products engaging with cross functional teams.
- Established and maintained quality control procedures and risk documentation ensuring compliance with industry standards and regulations, such as ISO 9001 and ISO 14971.
- Implemented Statistical Process Control (SPC) methodologies for a product assembly line, resulting in a 22% reduction in product defects within the first quarter of implementation.
- Conducted internal audits to monitor compliance with quality procedures and identified opportunities for process improvements.
Quality Engineer
Stryker Medical
02.2022 - 12.2022
- Performed QRQC (Quick Reaction Quality Control) to find the root cause of the issues faced in the shop floor of manufacturing department.
- Utilized SPC data to optimize production schedules, reducing lead times by 12% and ensuring on-time delivery of products to customers.
- Lead the incoming inspection team by performing FAI documents review with GD&T and product non-conformance management technique/work instruction.
- Lead the development and revision of PFMEA’s to identify and address critical risks.
- Provided engineering guidance to Stryker receiving including statistical analysis, measurement techniques, and Gage R&R studies.
Education
Master of Science - Industrial And Systems Engineering
University of Michigan
12.2020
Bachelor of Engineering - Mechanical Engineering
RGPV
Bhopal, India06.2016
Skills
- Quality Management System (QMS)
- Root Cause Failure Investigation (5 Whys, FTA, Fishbone Analysis)
- Statistical Methods (SPC)
- Quality Inspection and Control
- Current Good Manufacturing Practices (CGMP)
- Key Performance Indicators (KPIs)
- ISO Quality Standards
- Control Planning
- DMAIC
- Validation test protocols (IQ/OQ/PQ)
- Six Sigma
- Software - Valgenesis, Agile, SAP, Minitab,Tableau, MS-Office
Certification
- Quality Process Analyst (CQPA) certification from American Society for Quality (ASQ).
- Lean Six Sigma Green Belt certification from International Association for Six Sigma.
Timeline
Quality Engineer
Stryker Medical
02.2022 - 12.2022
Manufacturing Quality Engineer
Stryker
01.2022 - Current
Master of Science - Industrial And Systems Engineering
University of Michigan
Bachelor of Engineering - Mechanical Engineering
RGPV
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