Quality Inspector Assurance

JASWINDER

KAUR

**** ***** ******

Woodstock, IL 60098

Phone : 815-***-****

Email: *******@*****.***

OBJECTIVE

To obtain a position where I can multilayer of management skills, quality control, program development, training experience and a successful track record in the manufacturing environment.

SUMMARY

Highly motivated. Proven ability to initiate appropriate action, follow instructions, problem solver and carry out tasks in an efficient manner with communication skills.

ACCOMPLISHMENTS

ISO & TS19649 Internal Auditor, Blueprint Reading, Technical Mathematics, Quality Control Instrumentation and Industrial safety, Computer and Internet skills, Microsoft Excel, Microsoft word/ Outlook 2003,2007and 2010, Power

Point skills, Perfect attendance.

EDUCATION

BACHELOR OF ARTS Punjabi University Patiala-India

DATE: 1989

MASTER DEGREE IN POLITICAL SCEINCE Punjabi University Patiala-India

DATE: 1993

SKILLS

Process analyzes, time study to check PCDA for new improvements -Toyota Production System. Conduct a root cause analysis and corrective action, keep always positive, Focused, Summarized, Explained, Communicated, Responsible, Motivated, Supported.

EXPERIENCE

QUALITY ASSURANCE INSPECTOR - LEICA BIOSYSTEMS

5205 Rt. 12 Richmond, IL 60071

DATE: 03/19/2019- TILL NOW

RESPONSIBILITES

Receiving Incoming Inspection

Final Inspection

Issue Non-Conformance Report

Pull Component master record index, specifications, inspection forms, drawings, functional, dimensional templates documents change orders and or reference any list that may apply.

Pull samples- Determine the number of containers from which to pull samples. Use the equation X= (N+1. {AQL}

Use receiving good receipts, specifications, drawings, artwork and inspection forms or any combinations of these that apply to complete the quality inspection and release in SAP for product use.

Make functional test by using IPC printers, and other Lab gauges like caliper, micro-meter, water test for glass slides.

Test Pre=shipments of cassettes & slide

Final inspection- inspect the product/ label / Revision/ order number and released in SAP for ship quality product to our customers.

Non-conformance Report- IF the product fails the specification, then submit the non-conformance report with full data included some pics if possible.

EXPERIENCE

QUALITY INSPECTOR - NOVATION INDUSTRIES

Blogger Road, McHenry IL 60050

DATE: OCT 2017- MAY 20TH 2018

RESPONSIBILITES

First Piece Inspection Process-

(Micro view and other instruments like Caliper, Micrometer, Height Gauge, Depth Gauge, Optical Comparator) contact lead person/Supervisor and communicate immediately any deficiencies in quality.

Micro view Layout-

Test 1st piece and In-process parts on micro view. Follow up with production leads/quality engineers on new developments through email if needed or any other form of communication.

Train operators on Visual Criteria and Standards-

Follow up with lead/supervisor after any deficiencies with personal on the assembly line to make on the spot corrections and on the spot training for the operators.

Help contain Nonconforming Material-

Follow proper procedures with personal whenever conforming material is found on the floor or in warehouse.

Generate Quality Alerts for problem issues-

Communicate with previous and following shifts on important issues that Were found or discussed and follow up with lead/supervisor.

Generate/Update Control Plans and Work Instruction-

Create new or updated new control plans. Take pictures and follow BOM to create new work instructions. Create 1st pieces and In-Process dimensions documents.

Conduct Measurements Studies-

Keep supervisor informed about the results and communicate to quality engineers

The same time.

Inspect raw and finished product for quality control.

Check the pressure of the Torque with Torque Analyzer.

Check Burst leak test

Check Tensile test

Create quality documents with instructions.

Daily Leak Data entry in Database.

EXPERIENCE

SENIOR QUALITY INSPECTOR TECHNICHIAN - NOVATION INDUSTRIES

1101 CORPORATE DRIVE, MCHENRY IL 60050

DATE: OCTOBER- 2010 TO JULY 11 2016

Receiving Incoming Inspection

Sterile Final Inspection

Final Inspection

Create Inventory Report

Create Gemba Report

Issue Non-Conformance Report

RECEIVING INCOMING INSPECTION-

Pull Component master record index, specifications, inspection forms, drawings, functional, dimensional templates documents change orders and or reference any list that may apply. Pull samples- Determine the number of containers from which to pull samples. Use the equation X=(N+1

Use receiving paper work, specifications, drawings, artwork and inspection forms or any combinations of these that apply.

Once the inspections are completed, Document on the product inspection log. Documents the sampling and test results and/or record functional and dimensional results on the appropriate forms. Review all the results to determine if the inspection is to be accepted or rejected.

Print coroner white label if needed. Print Green four-up label’s per Medela pass through finish good list.

If the result of the inspection is “Accepted” release the product in QAD/MFG-PRO. Complete the Quality Label Verification and Reconciliation for each label batch printed. Retain this form in the inspection packet. If status is “Rejected/Quarantined” follow Department Processor’s for proper steps to submit the nonconformances report against the product.

All of the inspection documents and records will be stored in the inspection packet for the product release.

Confirm all labeling steps were executed properly. If not properly executed, correct and proceed or issue Non-conformances Report if needed.

Instruments Used

Classic Electric Pump

Caliper

Lactina Pump

Pin Gauges

Optical Comparator

Micro view

Steel Ruler

Keyence Gauges

Freestyle Test Fixture

ISO 21247 Inspector Rule Cards

ISO 21247 Double Sampling Flowchart

ANSI ZI.4 Inspector Rule Cards

C=0 Sampling Plans

Scales

Sterile Final Inspection-

Warehouse receives product and stage for QC. QC to receive, sterile processing documents from supplier to proceed with inspection. Follow the inspection guidelines in the finished product specifications and DP perform and document the general product inspection. I will compare the cycle report provided by the contract sterilizer to the

Defined parameters in the product specification. Any indication of a sterilization process that was performed outside the defined parameters must result in a non-conformances report being generated.

Review all applicable paperwork to be included with the sterile lot release documentation to include.

Sterilization Process Parameters (This includes preconditioning,

Sterilization, degassing information, and Cycle process reference)

Receiving Summary (reflecting Pallet/case count)

Shipping Information from Medela (Number of pallets shipped to contract Sterilizer)

Preconditioning Record (room/location, Elapsed time, min/max temperature/

Humidity)

Degassing Room Record (Room/location, elapsed time, min/max Temperature)

Sample Test Request Form (indicating Applicable test devices, if appropriate)

Shipping information from Contractor (Number of pallets and weight shipped

From contractor)

Sterilizer Printout indicating sterilizer

Number, program name, NPS lot

Number and critical sterilization Parameters

Record the results of the following on inspection per DP

Verify of cycle parameters from the sterilizer per DP

Verify of BI testing per DP

Verify of Part number, Lot number, and Quantity on Device History Record to product received

Verify of Contract Sterilizer’s “Quarantine Material Awaiting Sterilization Test Results” sheet attached to each skid.

Verify of Identification Pallet/Cage for Shipment Non-Sterile Product attached to each h skid.

Verify of load inspection for damage per DP

Verify of release of pre-sterile Device History Record.

Verify of back-flush transaction and completed adjustment for any quantity of rejected product.

Verify of signed “Green Parts Inspected/Accepted Sheet/Labels” for each pallet and Device History Record.

Verify of removal of “Blue ‘Waiting for Final Release’ Status Sheet

Process Challenge Device (PCD) Testing

Verify the proper numbers of PCD’s were received for testing by checking both the EO sterilization number and Medela load number.

Reviews sterilization documentation.

Test PCD’s in incubators for 7 days.

Record contract sterilizer sterile run numbers, Medela load numbers, Sterilization date, PCD lot numbers and PCD expiration date.

Record total number of positive results and total number of EO exposed PCD’s tested in the incubation.

Final product release.

Final Inspection

To verify products, meet specifications, personnel performing, documenting, and verifying final inspection. Go to every line in production and inspect all different kind of sterile kits, Retail Kits and Pump in Style kits and fill out all required inspection form.

Create Inventory Report

Create all QAD inspection report daily basis at start of the shift that shows how products we need to inspect.

Create Gamba Report

Create Gamba report daily in end of the shift. Collect all data from all

Different areas and look for how much release and issues and

Nonconformance’s issues and update white board.

Issue Non-Conformance Report

Issue Non-Conformance report using Soft Smart system if the product failed inspection.

EXPERIENCE

QUALITY INSPECTOR – FABRIC MOLDED PASTIC

MCHENRY IL 60050

DATE: DECEMBER 1997-NOVEMBER 2003

RESPONSIBILITES

Inspect the parts with industrial instrumentation, Caliper, Micrometer, Optical Comparator.

Inspect raw and finished product for quality control.

Audit all parts and create new documents for all new models.

Contact this candidate