Quality Manager
Resume:
NARESH SODHI
***** ** ** ***** ***** Springs, FL 33065 – Phone (954) - 648-1210
OBJECTIVE
Senior level technical position as an individual contributor or as a team leader in the area of quality, reliability or manufacturing engineering.
PROFILE
Extensive and accomplished experience in high tech engineering, quality, reliability and management. A proven track record in new product introduction, problem solving and cost reduction. Demonstrated competencies in:
- Statistical Process Controls
- Quality/Reliability Engineering
- ISO 9000 Certification
- Supplier Quality Management
EXPERIENCE
BECKMAN COULTER, MIAMI FL 2014 - Present
Staff Quality/Reliability Engineer-New Project Manager with following responsibilities
- Ensured compliance with design control process from development through the end of life.
- Ensured Quality system compliance to ISO 9001, ISO 13485 and 21 CFR 820 regulations.
- Performed Risk Analysis per the ISO 14971and ensured that the Risk Management documents are maintained per the procedures.
- Implemented tools for Risk Management and Risk Mitigation tools throughout the product life cycle.
- Performed quality audits to ensure that the suppliers follow the documented quality system and to
ensure that statistical process controls are implemented.
-Monitored the yields at the suppliers, investigated the problems and implemented supplier corrective action for improvement.
- Provided technical guidance to define tests and procedures to qualify new suppliers.
- Set Reliability goals and provided reliability allocation for subsystems.
- Performed reliability prediction for the new products to ensure that product would perform well at customer sites and have a competitive performance edge in the market.
- Performed reliability testing in design and production phase. Resolved field Reliability problems.
- Supported the development of test methods in equipment, process and product qualification/validations.
- Developed and implemented process Quality control plans in accordance with product risk level and ensured that those plans were followed.
- Implemented product sampling plans for Reliability testing using Chi-Square distribution.
- Implemented sampling plans for process yields.
- Mentored engineers in various technical capabilities.
NIPRO DIAGNOSTICS, FORT LAUDERDALE FL 2012- 2014
Quality Engineer-New Project Manager
- Provided the leadership for Quality in “New Product Introduction” process.
- Participated in the product/process improvement as a quality Lead for different products.
- Performed Design FMEAs and Process FMEAs.
- Performed Risk Analysis per the ISO 14971and ensured that the Risk management documents are maintained per the procedures.
- Implemented Risk management throughout the product life cycle.
- Audited suppliers to ensure that the suppliers follow the documented quality system.
- Reduced inspection based upon the yields at Incoming Inspection and other process steps.
NARESH SODHI Page 2
NIPRO DIAGNOSTICS, FORT LAUDERDALE FL 2012- 2014
Quality Engineer-New Project Manager
- Performed reliability prediction for the new products to ensure that product would perform well at customer sites and have a competitive performance edge in the market.
- Performed EMC and Safety Analysis to reduce electromagnetic susceptibility, emissions and safety problems.
- Performed reliability testing in design and production phase. Resolved field Reliability problems.
- Implemented process for design controls
- Developed and implemented processes for IQ/OQ/PQ for different products
- Developed sampling plans for process yields and outgoing quality.
- Developed and implemented production and process controls
- Managed projects for different products.
RAYTHEON COMPANY, TUCSON AZ 2009- 2012
Joint Ordnance Assessment Deputy Manager
- Provided leadership to a team of reliability and quality engineers on the testing for product service life.
- Performed reliability prediction for the new products.
- Worked with customers to resolve quality and reliability problems.
- Performed reliability testing in design and production phase. Measured field reliability and resolved field problems. Performed Analysis of the Built-In-Testers for improvement of Test Coverage.
- Performed Fault Tree analysis and FMEA analysis.
- Established failure review and corrective action process.
- Supported Design reviews and Design Verification testing.
- Developed the “New Product Introduction” process for the Quality Organization.
- Worked with suppliers to resolve performance problems related to the subassemblies and components.
- Witnessed and approved the product testing at the supplier sites.
- Monitored supplier performance and implemented corrective action to improve Quality.
- Implemented process Quality control plans that are in accordance with product risk level and ensured
that the plans are followed.
-Mentored Engineer in various organizations on the application of Statistics in Quality and reliability.
MAKO SURGICAL, Ft. LAUDERDALE 2007 – 2009
Reliability Engineering Manager
-Built a successful team for EMC/Safety Compliance, Reliability & Design Verification tests. The product is a Complex electro-mechanical navigational Robot used to perform Knee Surgeries.
-Managed the team for EMC/Safety, Reliability Prediction, Testing, and Design Verification, Stress testing (HALT & HASS), Reliability Risk analysis, Fault Tree Analysis and FMEA analysis. Provided leadership for Reliability Improvement.
-Managed the department budgets and resources.
-Provided leadership for “Design Controls”.
-Established tools and methods for new product and process introduction.
-Participated in product/process improvement meetings and served as a primary contact to resolve issues with the products.
-Participated in failure investigation, developed and implemented the plans for corrective action.
-Established a process to review failures in Design and led the effort for root cause investigation and corrective action.
-Supported the development of test methods for equipment, process, product qualifications and validations.
NARESH SODHI Page 3
ALCON SURGICAL, ORLANDO 2001 - 2007
Senior Reliability Engineer
-Provided leadership role for the reliability effort on the Lasik Eye surgery product which was a
combination of electromechanical, electronics, Laser, Optics and software.
- Provided Quality Engineering and Customer support. Resolved issues related to the Reliability and Quality. Obtained approval for capital budgets, plans & schedules.
-Chaired Cross-Functional team meetings for the reliability, safety and design changes. Reviewed progress
against the goals, investigated problems, assigned action items and ensured that the team completed them
in a timely manner
-Performed the “Reliability Analysis” for the system & predicted MTBF (Mean Time between Failures).
Plan and per reliability testing to ensure that the demonstrated reliability meets or exceeds the
predicted MTBF. Used statistical tools to accurately measure the reliability from the test data.
-Performed the FMEA & Risk/Hazard analysis.
-Performed EMI& Safety testing and made changes in the design for Compliance.
-Performed Risk Analysis, Risk Mitigation, Verification and effectiveness of the Mitigation.
-Developed and implemented process Quality control plans in accordance with product risk level and
Ensured that the plans are followed.
-Mentored others in different technical disciplines.
EDUCATION
Punjab Engineering College, Chandigarh, India.
B.S. in Electrical Engineering
Corporate Sponsored Training
Project Management
Reliability Engineering
Statistical Process Controls
ISO-9000 Quality Systems
Certified QA Auditor ISO 9001and 13485
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