Pratik – Supplier Quality Engineering – 7+ years Exp – Willing to relocate anywhere in USA
Consultant's Details:
Consultant Name:Pratik
Employer Details:
Employer:Nextgen Technologies Inc
Contact Person:Kushal
Email:kushal.desai@nextgentechinc.com
Note: Please call between 09:30 AM PST to 06:00 PM PST
Phone: +1 (413) 424-0484
Pratik 's Resume
PROFESSIONAL SUMMARY
Certified Lean Six Sigma Green Belt (SSGB) and MS in Industrial Management with over 7 years of Supplier Quality Engineering, Supplier Management, and Quality Assurance across the medical device (ISO 13485) and automotive (IATF 16949) sectors. Proven track record in driving Supplier Quality Integration, managing high-volume part qualifications (PPAP/APQP), and stabilizing supplier performance during complex product transfers. Expert in DMAIC-based problem solving, IQ/OQ/PQ process validation, and SCAR/CAPA management. A results-oriented professional dedicated to ensuring regulatory compliance (21 CFR 820) and operational excellence through cross-functional leadership and data-driven root cause analysis.
CORE SKILLS
Supplier Quality Engineering, Supplier Quality Notifications (SQN), Supplier Corrective Action Requests (SCAR), CAPA, APQP, PPAP, Part Qualification, MRB Support, Root Cause Analysis (8D, 5 Why, Fishbone), Process Validation (IQ/OQ/PQ), Statistical Process Control (SPC), Measurement Systems Analysis (MSA), Process Capability Analysis, Supplier Assessments and Audits, Quality Documentation and Reporting, Nonconformance Management, Corrective and Preventive Actions, Cross-Functional Collaboration, Continuous Improvement, ISO 13485, IATF 16949, 21 CFR 820, SAP, Microsoft Office.
PROFESSIONAL EXPERIENCE
Philips Medical Devices Cambridge, Massachusetts (Remote) Quality Engineer -EI PMS and C&R Oct 2024 –Present
- Execute end-to-end complaint handling for EI-DMS, ensuring full compliance with 21 CFR 803/820 and ISO 13485 standards.
- Orchestrate cross-functional alignment across Supplier Quality, R&D, Regulatory, and Operations teams to ensure timely issue resolution and quality compliance.
- Deliver critical investigation evidence and documentation to support Supplier Quality escalations, CAPA activities, and SCAR follow-up/closure.
- Lead regulatory reportability assessments (MDR decision-making) and author technical justifications within the DMS-EI system.
- Partner with R&D, Clinical Specialists, and Product Management to synthesize investigation inputs and finalize complex complaint closures.
- Drive CAPA initiation and effectiveness verification based on complaint trends, L1/L2/L3 escalations, and post-market surveillance (PMS) signals.
- Facilitate internal and external quality audits by providing robust investigation records and technical documentation.
Magna International Excelsiors Springs, Missouri
Supplier Quality Engineer May 2024 -Aug 2024
- Reviewed supplier-related nonconformances with internal quality teams and supported material disposition activities for production issues in a manufacturing environment.
- Worked with suppliers on containment, correction, root cause analysis, and preventive actions to resolve supplier quality and product quality issues in a timely manner.
- Supported supplier corrective action follow-up and drove closure of quality issues through structured problem solving (DMAIC, 8D, CAPA, Fishbone).
- Executed APQP and part qualification activities, including PPAP approval and PSW sign-off for 256 foam parts to ensure production readiness.
- Performed MSA, process capability studies, PFMEA, and Control Plan support, contributing to process validation and verification.
- Collaborated with Supply Chain, Manufacturing, and Engineering teams to improve supplier performance and manufacturing quality.
University of Central Missouri Warrensburg, Missouri
Graduate Assistant (GA) Aug 2023 – May2024
- Supported instruction in quality systems, root cause analysis, CAPA, and regulatory fundamentals relevant to regulated industries.
- Assisted in teaching quality tools such as DMAIC, 5S, Quality Management Systems, and Fishbone
- Assisted with data analysis, documentation, and process improvement case studies emphasizing investigation rigor and compliance.
ELGI Equipment’s Ltd Hyderabad, India
Senior Supplier Quality Engineer Nov 2021 – Dec 2022
- Led supplier quality assessments and supplier audits, working with suppliers to resolve nonconformances impacting product quality and manufacturing processes.
- Drove supplier corrective actions (SCAR/CAPA) through containment, root cause analysis, and follow-up verification using DMAIC-based structured problem solving.
- Supported part qualification and process validation activities through inspection reviews and documentation.
- Coordinated with manufacturing, sourcing, and engineering teams to improve supplier performance and ensure quality compliance.
- Analyzed supplier and production quality data to identify trends, support continuous improvement, and enhance supplier management performance.
Flowserve Sanmar Pvt Ltd Chennai, India
Senior Quality Assurance Engineer July 2020 – Nov 2021
- Led complaint data reviews for CAPA and Corrections & Removals (C&R), ensuring compliance with FDA-aligned quality system requirements.
- Supported regulatory audits and inquiries by preparing complaint files, investigation documentation, and safety escalation records.
- Collaborated with cross-functional teams to standardize complaint handling and adverse event escalation processes.
Adani Wilmar Ltd. Nellore, India
Quality Assurance Engineer Aug 2016 – Jan 2019
- Led DMAIC projects to improve injection molding quality, achieving a 15% reduction in defects and enhanced compliance with ISO 9001 and ISO 14001.
- Applied DFM/DFA principles during product design reviews, integrating manufacturability and assembly considerations to reduce production waste and assembly time.
- Conducted supplier process audits, capability studies, and quality reviews to ensure alignment with corporate quality standards and environmental compliance.
EDUCATION
University of Central Missouri, Warrensburg, MO Jan 2023 – May 2024
Master of Science in Industrial Management
Vignan Institute of Technology and Science, Hyderabad, India Aug 2011 – May 2015
Bachelor of Technology in Mechanical Engineering
CERTIFICATIONS
Certified Six Sigma Green Belt Henry Harvin Education – 2021
Lean Six Sigma Graduate Certificate University of Central Missouri – 2024
LEADERSHIP ROLE
University of Central Missouri Warrensburg, Missouri
Vice President UCM- ASQ Aug 2023 – May 2024
- Assisted in teaching quality tools such as DMAIC, 5S, and Quality Management Systems to students, guiding their understanding and application in quality improvement initiatives.
- Collaborated with faculty and industry professionals to develop a streamlined Lean Six Sigma curriculum, reducing program completion time by 30% for students.
Note: Please call between 09:30 AM PST to 06:00 PM PST
Kushal
| 1735 N 1St ST., Suite 308 |San Jose, CA 95112
NextGen Technologies Inc
Email: kushal.desai@nextgentechinc.com. Website: www.nextgentechinc.com | +1 (413) 424-0484 |
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Sr.SQE-Pratik-Palukuru.docx