Quality Engineer Engineering

BHARATHI.N

Quality Engineer

+91-995******* **********@*****.***

Looking for a challenging job in an industry where I can utilize my Education and the organization and self-growth. Quality Engineer (OCT 2017-Present)

CURA Healthcare Pvt. Ltd

Inspecting the Incoming materials from vendors as per the drawing and maintaining the record of it.

To prepare the rejection report for the incoming materials, highlighting to the suppliers and getting the CAPA

To inspect the machine according to the plan and maintaining a record of IPQC & FQC

To prepare weekly, monthly report for the inspected items and reporting the same to top management.

Certified internal auditor for ISO13485:2016

Conducting the internal audit as per the schedule and preparing the audit result & follow up for CAPA

To generate the calibration master list for over all departments and coordinating with the purchase team, for calibrating the equipment’s whenever required

Conducting the supplier audits/surprise audits and preparing the supplier evaluation and maintain the record of it.

To source the new & existing parts, getting RFQ, Negotiating the price from the supplier and follow up procuring the same

Designing/Reverse Engineering the parts as per the requirement and sending to vendors and receiving the same

FAI is done for parts developed and approving the same for pilot & mass production

Getting the materials according to the production schedule and PO in the timely manner without affecting the delivery Packing verification done for the machine against the dispatch and maintaining the record

Education:

2009-2012 Mahendra

Engineering college,salem

B.E – Mechanical Engineering

2007-2009 Elumalai

Polytechnic college,villupuram

Diploma – Mechanical

Engineering

2006 Jawahar sec. school

10th standard

Objective:

WORK EXPERIENCE

Additional Responsibilities:

Skill set:

Problem solving

Team working skills

Leadership skills

Effective Communicator

Software skills:

Solidworks

Auto cad

MS Office

2

Quality Engineer (Jan 2015-Sep 2017)

Shimadzu Medical India Pvt. Ltd

Inspecting the Incoming materials from vendors as per the drawing provided and maintaining the record of it

Follow up with the suppliers and getting the replacement/claim from the suppliers for the rejected parts

Preparing and maintaining ISO 9001:2008 related documents from level-1 to level-4

Conducting/ Appearing for internal audits, supplier audits as per the schedule prepared and document the same as per ISO9001:2008

To engender the calibration master list for over all departments and coordinating with the purchase team, for calibrating the equipment’s whenever required

To verify the assembled machines before dispatching the same

Reverse Engineering done for the parts whenever required and documenting the same

FAI is done for new/developing parts and approving it for pilot and mass production

Preparing and maintaining documents of IS 7620 Diagnostic Medical X-ray Equipment, Part 1: General and Safety Requirements

To prepare the installation manual, brochures and part list for the products

Preparing and maintaining the AERB documents and maintaining the same as per the AERB regulations

Creating new part drawing for the machines, sending it to supplier and getting the same and assemble with the machines.

Maintaining the 5S, 3C in shop floor and in quality area. Asst.Quality Engineer (Sep 2012-Jan 2015)

Foxconn Technology India Pvt. Ltd

Skilled in analyzing the customer drawings and preparing the Standard inspection procedure as per the customer drawings

Preparing the Quality related documents such as SOP, Control Plan, PFMEA, Inspection Standards & OQC IS

Developing, Introducing and Reviewing of Trail parts for new products

Preparing SPC charts for critical parts

Preparing FAI,GRR, CP & CPk reports to customers report for new projects

Fair knowledge 7QC tools,3C & 5S Concepts

Preparing 8D reports for customer complaint

Certified internal auditor for ISO 9001:2008 & 14001:2004

To generate the calibration master list for over all departments and coordinating with the purchase team, for calibrating the equipment’s whenever required Additional Responsibilities:

Additional Responsibilities:

3

To verify/ensure the FPIR and In-process report according to the production done as per the sampling plan

To verify/ ensure all scraps raw materials, in-process products, finished goods, customer returns.

Preparing and maintaining the ISO documents in DCC from level-1 to level-4 (9001:2008 & 14001:2004) and uploading the documents and records in web portal

To Create and provide ECN # to documents Change whenever the new or old documents are reviewed and revised

To prepare and maintain the master list of procedure and preparing the quality procedure matrix

To raise the purchase request for the instruments and consumable required according the quotation given by purchase team and follow up of those materials

To support the supplier quality engineer to authenticate the incoming rejections and highlighting to the appropriate suppliers

Going to customer end for customer complaints and performing the containment action, finding root cause for the complaint and implementing CAPA

Preparing weekly and monthly reports to customers

Involving in the kaizen activity for reducing the packaging cost and recycling the pallets Place : Chennai

Date: Signature

(N. Bharathi)

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