Smita Patel

** ***** **. ***** **********, NJ ***80

Cell: 908-***-**** Home: 908-***-****

Email: adgmfx@r.postjobfree.com

Objective:

To obtain a challenging position in a lab and to further expand my knowledge and experience as a Quality Control/Assurance Inspector. To be part of the medical device industry knowing that what I do saves countless lives. To work with a team and be able to together share knowledge and ideas to make the future of the medical device industry even greater.

Instrumentations:

Smart Scopes (Optical / video Cordiant Measuring Machine)

Chantillon Tensel / compression machines

Deltronic Optical Comparators

Burst testers

Leak testers

Micrometers

Vernier Calipers

Microscopes

Pin gauges

Bore gauge

Software:

MSOffice

JDE

Data-Works

TrackWise

Professional Experience

Viant Medical South Plainfield N.J. September, 2018 to Present

Quality Assurance Inspector

Responsibilities:

Blue project (Validation)

Checking & Signing Line clearance’s

Inspecting daily production start-ups

Inspecting daily samples from production

Run OGP systems using fixtures and inspection programs.

Perform visual and mechanical inspection using calipers, micrometers, pin gages, bore gauge, and optical comparators

Collecting data and preparing paperwork associated with part validation for new projects

Documenting test and inspection results and updating database accordingly

Reliance Vitamin CO INC., Edison NJ September 2015- September, 2018

Quality Assurance Inspector

Responsibilities:

Matching up bill of materials with staged products and corresponding Production Set up Sheet.

Inspecting line set up and line clearance.

Comparing the information filled in by the Line operator against the bill of materials, bulk lot and components for accuracy.

Reviewing the comments, notes or special instructions on the bill of materials to confirm all instructions are being followed.

Confirm that the product information has been placed on the product movement sheet.

Providing samples for QC lab and customers who require packaging.

Updating the Cleaning-Set Up Maintenance Log Book for appropriate products.

Release of the product.

International Techinidyne Corporation (ITC), Edison NJ January 1991- May 2015

Mechanical/Electrical Quality Control Inspector Level III 2000-2015

Responsibilities:

Performed First article inspection, Validations and in process inspection for the molding, assembly, and packaging departments.

Inspections performed using MIL STD 105E, ANSI/ASQC Z 1.4, ISO 2859-1 Standards 2008, and C=0 Sampling plans.

Reviewing documents using cGMP, cGDP, and SOP’s

Sampling and inspecting incoming, in-process and finished product.

Performed review of Document History Record (DHR) to ensure accuracy and completion.

Review and release of Incision, Molding, final product, Incoming inspection goods, and other raw materials.

Entering test results into computerized material management system.

Performed validation and investigative LSR (Laboratory Service Request) inspections to support various departments such as Customer Complaints, R&D, and Quality Engineering.

Responsible for issuing NCR (non-conformance reports) for nonconforming products.

Followed standard operating procedures (SOPs) to perform functional tests of electro/mechanical diagnostic medical instruments.

Machine Operator 1991-2000

Responsibilities:

Operated a variety of manufacturing equipment as necessary including Datum machines for Tenderfoot and Tenderlett devices (Disposable medical devices).

Identified, notified and helped prevent damage to product, material, labels and other components. Familiar with vision systems equipment to check and verify the assembly of the device.

Prepared labels for various packaging which includes several medical devices

Performed assemble work related to various manual Surgicutt/Tenderfoot assembly and other assembled parts.

Filling out forms for line clearance and in-process assembly requirements for lot to lot operations.

Education and Training

B. S. Accounting Gujarat University Gujarat, India

Blueprint Reading Middlesex County College Edison, NJ

ESL Classes Middlesex County College Edison, NJ

Good Documentation Practices (ITC Corporation) Edison, NJ

Lean Manufacturing, Process Mapping (ITC Corporation) Edison, NJ

Geometric Tolerance (ITC Corporation) Edison, NJ

M.S. Office (Word, Excel) Middlesex County College Edison

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