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Quality Engineer, Industrial Engineering, Supply Chain

Santa Clara, California, United States
October 10, 2016

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Subhadra Rajasekaran Phone: +1 (973) 302 – 3451


Goal-oriented industrial engineer with 2 years of experience in quality and supply chain role in medical device and automobile industries, looking for a full-time opportunity in similar positions.

Areas of Expertise

Core competencies – Risk analysis, New Product Development, Reliability assessment, Lean Manufacturing, Six sigma, SPC, DOE, Gage R&R, GD&T, Hypothesis testing, Demand/Forecasting, Inventory management, Failure Mode Effect and Criticality Analysis (FMECA), PPAP, FAIR, APQP, FMEA, RCA, 8D, CAPA, cGMP, cGDP, VSM, DFM, JIT, TQM

Software tools - Minitab, CAD, SolidWorks, SQL, SAP, Agile PLM, Matrix, Enovia 3D, QMS, Advanced MS Office (Excel, Word, PPT), MS Visio, MS Access, MS Sharepoint, ARENA Simulation, Simio, Simulink, Matlab, Adobe Acrobat, C++, RSlogix

Certification- Problem Solving and Decision Making (Kepner-Tregoe), Advanced Excel (Access Analytic)

Work Experience

Medtronic Inc (Mar 2016 – Present)

Design Assurance Engineer Plymouth, MN

●Created risk management reports and risk documents such as PHA, DFMECA & PFMEA for the DHF Remediation project.

●Implemented post market surveillance plans for new and legacy commercialized peripheral vascular products.

●Worked on compliance regulation for legacy products to meet ISO 13485, ISO 14971, FDA QSR and 21 CFR 820 standards.

●Audited Design History File for HawkOne catheter starting from concept to validation phase as an independent reviewer.

●Authored PIA reports on field complaints, identified causes for non-conformities by root-cause analysis using fishbone, 5-Why, 8D, FTA and devised action plans.

●Developed design verification, design validation, process validation reports and also drafted master plans for GuideWires.

●As a part of DHF Remediation project, wrote leverage reports for sterilization, biocompatibility, packaging and labeling.

●Successfully worked with the complaint handling team in the Customer Experience Reports (CER) and presented them with P-chart metrics during the Product Evaluation Committee (PEC) meetings.

●Providing sustaining engineering support for product development teams.

Transfer Quality Engineer

●Successfully completed the transfer of test methods for plaque excision device manufacturing lines from CA to Ireland.

●Reviewed validation reports, identified gaps for GMP compliance and developed remediation strategies.

●Created and analyzed test methods for finished goods, in-process testing and receiving inspections.

●Developed sampling plans and wrote Gage R&R protocols and reports for Directional Atherectomy Catheters.

●Performed Measurement System Analysis (MSA) and investigated the results produced by statistical process control tools like Pareto charts, histograms, box plots, scatter diagrams, etc.

●Coordinated the development and execution of validation life activities which includes IQ, OQ, PQ protocols.

●Documented non-conformities as part of the CAPA reporting process in the Corrective Action Tracking System.

●Assisted the Test method Integration team in updating SOPs with redlines and creating Engineering Change Orders (ECO).

Terumo Cardiovascular Group (Mar 2015 – Feb 2016)

Validation Engineer Ann Arbor, MI

●Authored attribute and variable test method validation protocols and reports for Heart Lung Machine, Machine Shop and Incoming Quality Assurance (IQA).

●Assisted the R&D team in creating lab studies on torque specs and tests procedures for validation studies.

●Performed Gap Analysis on Design FMEA of the product and Process FMEA of the manufacturing process to ensure compliance with end user specifications.

●Conducted reproducibility and repeatability studies, DOE, ANOVA using Minitab for process characterization.

●Identified process capability and performance requirements (Cpk, Ppk) of CTQ features.

●Validated test fixtures, test assemblies and gages by performing IQ and EQ.

●Responsible for creating component specifications and testing criteria from IQC to Final QC.

●Successfully created and managed BOM's, Router's and drawings to accommodate MFG, planning and supplier needs.

●Participated in Material Review Board (MRB) meetings and worked on resolving various NCMRs.

Supplier Quality Engineer

●Developed key process indicators (KPI) for customer complaints, warranty returns, and process controls.

●Worked with customers to meet specific PPAP, FAIR and APQP documentation requirements.

●Met with suppliers to review Supplier Quality Performance and to resolve non-conformity issues.

●Identified negative/ positive trends and generated Supplier Corrective Action Requests (SCAR) for root cause analysis.

●Created quality plan, reviewed supplier processes and ensured adherence to 21 CFR 820.75.

●Performed trend analysis to close multiple open CAPAs and worked with independent reviewers to ensure FDA compliance.

Renault Nissan Automotive India Pvt. Ltd (May 2014 – Sep 2014)

Supply chain Intern Chennai, India

●Implemented lean manufacturing principles in scheduling for timely distribution of finished cars. Used MODAPTS time system to calculate the manufacturing cost, time requirements and resource allocation to measure operational performance and improve production line throughput.

●Ensured adherence to 5S, Kaizen concepts for improvement of manufacturing procedures and possible labor reduction.

●Developed Excel tracker to perform logistics calculation on the procurement of car parts and identified low to high consumption category for achieving optimized inventory management target levels.

●Assisted with CPFR process for key customers and used six sigma concepts to escalate the packaging issues of car parts, which resulted in increased workspace utilization, reduced transportation and storage cost.

●Worked on inbound and outbound logistics, suggested continuous quality improvement ideas that impacted the supply and demand changes.


Design of Embellished Emergency Room Simulation model (Sep 2014-Dec 2014)

Designed and simulated the working process of a hospital emergency room model using Arena Simulation and implemented OptQuest technique to reduce the delay time for critical patients from 2 hours to 30 minutes. Improved 28% overall profit gained by restructuring the layout using 3-D Visual designer.

Analysis of Hospital metrics and Cost Optimization (Sep 2013-Jan 2014)

Performed statistical analysis to optimize the excess cost incurred for hospital maintenance. Implemented lean principles and value stream mapping to reduce the non-value added activities in the hospital.

A Smart Speakerphone for the speech impaired using RedTacton Technology (Feb 2014- May 2014)

Designed a headphone with intervention of RedTacton technology (Human Area Network) and sensors, to interpret brain signals and give voice to the speech-impaired.


New Jersey Institute of Technology GPA: 3.8/4

Master of Science in Industrial Engineering (Specialization in Quality and Supply Chain) Jan, 2015

Anna University, India GPA: 8.3/10 Bachelor of Engineering in Electronics and Instrumentation May, 2013

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