Megha Kunjam
Supplier Quality Engineer
Northridge,CA
Summary
Over 6 years of experience in various operational roles, adept at problem-solving and root cause analysis using QC tools. Detail-oriented team player with strong organizational skills. Ability to handle multiple projects simultaneously with a high degree of accuracy.
Overview
9
9
years of professional experience
Work History
Sr. Quality Engineer
Medtronic
1 2023 - Current
- Experienced medical device professional with expertise in regulatory compliance (FDA 21 CFR Part 820, MDSAP, MDR, ISO 13485) and cross-functional collaborator.
- Possesses strong technical skills in Quality Engineering, including problem solving, analysis, and statistical methods (DFMEA, PFMEA, TMV, six-sigma, 5S, Gemba Walk, CAPA).
- Proficient in quality control methodologies including PPAP, Supplier Audits, 7 Quality Control (7QC) Tools, Statistical Process Control (SPC), and Gauge Repeatability and Reproducibility (Gauge R&R).
- Collaborated with cross-functional teams to optimize design, manufacturing, and validation processes
- Streamlined production lines for increased efficiency, reducing defects and minimizing waste
Lead Supplier Quality Engineer
Abbott- Sylmar
09.2021 - 01.2023
- Worked on Good documentation Practices, Supplier Change Notification, Data Integrity.
- Worked on Supplier Change Request, qualifying new suppliers and monitored the performance of current supplier based on SCAR, NCMR reports.
- Assisted Quality department to maintain compliance to the Quality Management System, Quality management priorities and all relevant local processes and procedures.
- Maintained relationships with suppliers and maintain the Approved Supplier List (ASL).
- Managed Supplier Corrective Action Report (SCAR) program, review SCAR responses for acceptability.
- Collaborated effectively with internal teams and external vendors to deliver high-quality, cost-effective solutions under tight deadlines.
Sr. Supplier Quality Engineer
Philips- Invivo Corporation
03.2020 - 09.2021
- Reviewed First Article Inspection, LRP-PSW Reports and log sheet.
- Monitored critical KPIs to ensure customers are reporting accurately & timely.
- Ensures products meet the organizations and customers' quality and product integrity requirements.
- Assists in the development of new & existing suppliers by improving their quality management system to improve overall product & documentation quality.
- Managed initial sample / part approval inspection, critical to quality and critical to safety with the Advance Production Quality Planning (APQP).
- Spearheaded risk management and identification within cross-functional teams, secured error risk analysis (PFMEA) and design risk analysis (DFMEA), Design History Files (DHF) and Design History Records (DHR).
Supplier Quality Engineer
State Government Authority
06.2015 - 02.2018
- Wrote process flow diagrams, qualification protocols, traceability matrices, and equipment requirement documentation for plant-wide Systems.
- Reduced product defects by closely monitoring supplier production lines and providing regular feedback for improvements.
- Performed an integral role in new product launches including both supplier and parts development for manufacturing (PPAP).
- Performed the Supplier Audits and evaluated quality issues.
- Created, maintained, and utilized forms such as SCAR (Supplier Corrective Action Requests).
- Analyzed supplier-side quality issues, facilitated Root Cause Analysis (RCA), and implemented corrective actions to ensure long-term resolution.
- Evaluated supplier proposals, conducting thorough assessments of their capabilities to meet organizational requirements
Education
Master of Science -
Indiana Institute of Technology
Fort Wayne, IN 05.2001 -
MBA -
Stratford University
Falls Church, VA 05.2001 -
Methodology and Tools
Methodology and Tools: JIT Project, 5S, 5-Why, Value Stream Mapping, A3's, DFMEA, PFMEA, Fishbone, FTQ, OQW, 5-Why, TMV, MVP-MVR.
Validation
21 CFR PART 820, PART11, ISO:13485, 14971, GMP, cGMP, cGMP, Critical to Quality and Critical to Safety, APQP, PPAQ, Test method validation (TMV).
Software
SAP, Windchill, Statistical Process Control ,Trackwise, Minitab, Tableau, SQL, MS Word, Microsoft Project, Microsoft Excel, PowerPoint, MS-Office, MS-Team, MS- Outlook, Power BI, Computer Integrated Manufacturing, Agile Product lifecycle Management.
Courses Certificates
- Six Sigma Green Belt- Project Management Institute
- Lean Management for All Sectors (Dutch BKO Accredited)- Six Sigma Academy Amsterdam
- Supply Chain Foundation- National Association of State Boards of Accountancy
- Six Sigma Yellow Belt- University System of Georgia
- AUTOCAD- Certified- CRISP Academy
- Computer Integrated Manufacturing- Indiana Tech
- Project Management - Public Welfare Department India
Leadership Experience
- LA Court-appointed special advocate (CASA) volunteers advocate for the best-interests of children who have experienced abuse or neglect.
- Leader in Asian in Medtronic (AIM)
References
- Harleen Kaur- Harleen.kaur@medtronic.com Phone number: +13854398422
- Isha Sharma- Isha.sharma@medtronic.com Phone number: +15102921948
Timeline
Lead Supplier Quality Engineer
Abbott- Sylmar
09.2021 - 01.2023
Sr. Supplier Quality Engineer
Philips- Invivo Corporation
03.2020 - 09.2021
Supplier Quality Engineer
State Government Authority
06.2015 - 02.2018
Master of Science -
Indiana Institute of Technology
05.2001 -
MBA -
Stratford University
05.2001 -
Sr. Quality Engineer
Medtronic
1 2023 - Current