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Mechanical Engineer Quality

Jersey City, NJ
October 21, 2018

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*** ****** ***, ****** ****, NJ,07306



More than 2 years of experience, I have been working as a Mechanical Engineer working in the medical device in the areas of manufacturing and quality control. I am also familiar with plastics industry manufacturing processes. With strategic quality planning and Quality function deployment (QFD), I can offer a quick transition to enhance yield, productivity and reduce cycle time, rework and scrap.


Design Softwares : AutoCAD, Ansys, Solidworks, Minitab,

Completed certified six sigma green belt course and lean processes.

Great ability to lead a huge management. Experienced in leading a team

Understanding of compressor, heat exchangers and refrigeration system.

Experience about manufacturing processes, heavy equipment processes, quality Control, manufacturing analysis-lean manufacturing, assembly department, Reliability Engineering, Failure Analysis, Root Cause Analysis, CAPA, design control, validation, Geometric standards and calculation, Injection Molding, Process Engineering, R&D for Manufacturability, Mass Manufacturing, Cost Controls / Scrap Reduction, Design of Experiments (DOE), 5 Whys Analysis, Preventive Maintenance (PM), 5s. Certified of Udemy six sigms green belt.

Excellent communication skill to work.


Nutra-Med Pacakaging, Whippany, NJ Feb 2018- Present

Quality Engineer

Led Kaizen and other improvement activities including PDCA, 5S, six sigma, Kanban.

FDA and ISO Standards in medical devices such as FDA 21 CFR part 210, part 211 and 820, ISO 13485.

Maintenance of the Approved Supplier List (ASL) in conjunction with the Global Sourcing, Supplier Controls and Audit functions.

Responsible for labeling of product shipper, and bottling and also barcode labeling.

Making of finished product identification and raw material and scrap.

Leading team and playing a key member in a team.

Responsible for NCMR, CAPA and root cause analysis such as 8D, 5W.

Evaluate QMS (Quality Management System) processes to comply with FDA 21 CFR part 820, part 803, ISO 13485.

Responsible for DHR, DHF and Sops. Also taking care of all documentation and batch record of all packaging details. Provide support to Internal/ External Customer groups on compliance issues related to assigned suppliers

Assists audits of finished products, final inspections, returned and serviced products. Investigate customer complaints for product quality issues and document requirements for investigations.

Work with manufacturing, R&D, Medical Affairs, and international affiliates as required. Quality, Regulatory and Compliance, to insure complete and thorough investigations.

Expert at assessing and evaluating workplaces for safety/ergonomic hazards, creating and documenting assessments making recommendations for effective hazard control management.

Experience of doing IQ, PQ and OQ of slot and v2 machines.

Participate in the supplier material related processes which include such as Material Review Board (MRB)

Maintains safety files and records. Provide Safety Training. Study and analyze hazards and accidents.

Advics Manufacturing Inc., Lebanon, OH Aug 2017- Jan 2018

Quality Engineer

Extensive experience in Quality Control, design control, Root Cause Analysis(router update and routings), implementing CAPA, Process validation, Packaging validation and Continuous improvement processes including PDCA, kaizen, six sigma, lean manufacturing and tools, 5S, analysis current state process and methods.

Work with production team members for Implementing of six sigma and lean manufacturing techniques for continuously increase process work flows to maximize efficiency, reliability and effectiveness of the system.

Associate the team in specifications to facilitate clear direction for new product

development requirements.

Generate, manage and modify all necessary design (2D, 3D) for using Computer Aided Design(AutoCad) and solid work & analysis of strength and deformation had been done by FEA and VSA and closely work with CAD team.

Participate in troubleshooting of manufacturing problems and related tooling, equipment or process issues through Root cause analysis (Fishbone, 8D, 5W) and Corrective actions or Preventive actions (CAPA) had been taken to prevent occurrence or recurrence.

Responsible Quality Improvement activities for all Plant manufacturing issues.

Coordinate new product launches and repurposed existing equipment on machine lines.

Evaluate QMS (Quality Management System) processes to comply with 510(K),FDA 21 CFR part 820, part 803, ISO 13485.

Interpret production drawings using Geometric Dimensioning and Tolerance (GD&T) and make Bill of Materials (BOM) for all brake assembly.

As a team key player, associate production line. Responsible for DHR, DHF. Review SOP’s and gauge R&R in minitab and worked with internal and supplier audits.

Work Cross functionally with production team for in Process Development, Process validation, Equipment selection and Process flow activities in manufacturing operation.

Manage line efficiencies with a focus on safety and ergonomics.

Analyze Process Validation test data to determine whether systems or processes have met validation criteria or to identify root causes of production problems.

Involve in Maintaining and documenting accurate design and manufacturing records including Engineering drawings, Supplier’s part specifications, production process specification, acceptance criteria for quality assurance, FMEA’s, Control Plans and internal test results.

Develop and maintained Process Flow Diagrams (PFD) for Planning, organizing and managing overall activities from receiving inspection to final inspection and Controlled packaging, labeling and shipping. Also, ensure material or parts have been moved to Shipping with appropriate paperwork and documentation

Influencing Quality and Production to realize cost reductions through greater efficiencies.

Surgicraft Industries, Ahmedabad, Gujrat, India July 2014-Dec 2015

Quality Engineer

As a Mechanical Engineer worked on manufacturing of Autoclave machine, sterilizer, and supplier management and got knowledge manufacturing of processes.

Utilized Manufacturing of Autoclave machine and sterilizer and got knowledge of process. Worked on CNC machine processes and assembly of parts and customer services and maintenance.

Conducted extensive and ongoing risk-based assessments of supplier corrective action (CAPA) solutions while recommending and implementing client-specific consultations and authored Technical reports, Equipment and Material Specifications.

Evaluated ECN changes for existing products, assists in testing, and validation.

Authored process validation (PV) protocols and reports of installation qualification (IQ), Operation qualification(OQ), performance qualification(PQ) and performed Gap analysis of legacy documentation to meet external/internal standards in medical devices.

Responsible for supplier management, including qualifying new suppliers, conducting root cause analysis for non-compliant suppliers.

Responsible for efficiencies and focusing ergonomics and safety also taking care when any hazard situation comes up.

Maintained documentation control of processes and quality related documents according to GMP (Good Manufacturing Practice) regulations and Central Drug Standards Control Organization (CDSCO).

Conducted FMEA, and particulated assessment at different stages of product cycle.

Used to deal with different supplier audits. Lead in change management system

Advanced computer skills, including statistical/data analysis (such as normality assessment, k-factor,t-test, safety factor, process capability, etc.).

Responsible for assuring products conform to established requirements and standards through appropriate audit, inspection, and test activities.

Responsible for DHR document for a product device. .

Advanced computer skills, including statistical/data analysis (such as normality assessment, k-factor, t-test, safety factor, process capability, etc.).

Troubleshoot process lines to make sure smooth equipment functionality. Created training plans for supervisors and operators on improved process steps. Worked with external vendors to meet production needs.

Worked on injection molding process and procedures and also familiar with plastics industry manufacturing processes.

Develops and implements corrective/preventative action plans. Creates, evaluates and dispositions NCRs (Nonconformance Record Reports).


Convection Heat Transfer

Reliability Engineering

Project Management

Engineering Analysis

Optimization in Engineering

Internal Combustion Engineering

Turbomachinery Design

Alternative Energy System

Composite Fluid Dynamics

Thermal Research Science


Gannon University, Erie, PA, USA Jan 2017-Jun 2017

Title: Advance in Photovoltaic

Reviewed previous research articles regarding solar energy and its characteristics.

Researched recent articles on photovoltaic cells.

Compiled report on solar system, photovoltaic system.

Gannon University, Erie, PA, USA Jul 2016-Aug 2016

Title: Work Break-Down Structure on an Elementary School

Made a WBS, Precedence Chart, And Critical Path Calculation.

Worked and led the team of 3. Calculated required sources and reviewed individually.

Presented in Class and submitted report.

Gannon University, Erie, PA, USA Jan 2017-Jun 2017

Title: Quality Functional Deployment

Prepared House of Quality of Toaster Oven.

Focused on Importance of QFD.

Presented briefly about Customer Wants and Technical Characteristics.

Ganpat University, Mehsana, Gujarat, India Aug 2014-Jun 2015

Title: Vibration Signal Analysis of Bearing

Worked with a group of 2 other individuals, dividing work based upon each group member areas of strength

Analyzed defected bearings to determine bearing life.

Utilized Vibration Analyzer to measure parameters and made peak to peak and amplitude graphs using Omnitrend software.

Presented findings to class and instructor.


Attend webinar of sensors national instruments

Studied different types of sensors

Participated seminar on gear box design

Acquired information about parameters of design


Gannon University, Erie, PA

Master of Science in Mechanical Engineering

Ganpat University, Mehsana, Gujrat, India

Bachelor of Technology in Mechatronic Engineering

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