Document Control Manager

RESUME

ESHA DEEPAK VENGURLEKAR

E-Mail: ****.***@*****.***

Mobile: +974-********

Date of Birth: 23rd March 1986

Place of Birth: Nasik, Maharashtra

Address: Villa 185, Behind Lulu Hypermarket, Al Khor, Qatar.

Permanent Address: Near LIC office, Basveshwara Nagar, Mundgod, Uttar Kannada Karnataka

Passport: T9410529

Visa Visit Visa

SYNOPSIS

A skilled and competent professional with nearly 13 years of experience in Quality control & Assurance, Document control in Manufacturing industry

Possess good knowledge of Quality control, Quality Assurance and Production.

Carries a positive attitude, enthusiastic and a firm believer of team work.

Ability in learning new concepts quickly and communicating ideas effectively.

CAREER FORTE

Infinity Medical Equipment Testing and Calibration Laboratory

Title- Quality Manager

Since May 2017 till October 2018

Responsible for preparing the quality manual of the lab in a way that achieves the technical goals of the lab conforming with the Dubai accreditation requirements of ISO 17025.

Responsible for notarizing the quality system including: Quality Manual, Procedures, Calibration procedures, Calibration certificates, records.

Responsible for preparing the plans for the quality system internal audit, and determining the personnel responsible for the auditing.

Responsible for constantly supervising the fulfillment of the accreditation demands.

Responsible for assuring corrective and preventive actions are being carried out to measure their efficiency.

Responsible for assuring that only the recent issues of the quality system are being used, and that the old documents are not accessible to the rest of the staff.

Responsible for preparing and supervising the management reviews

Responsible for reviewing and approving Calibration Certificates.

Responsible for representing the Management to ensure the implementation of Quality Management System.

Responsible for approving the uncertainty budget.

Responsible for maintaining the traceability of the labels issued.

Responsible for participating in the external and third-party audits.

Responsible for Releasing of Calibration Labels.

Establishing and Maintaining document control of all technical and quality document

Conformity Certification Services, Dubai, UAE.

Title- Sales & Marketing Incharge

Since January 2017 - April 2017

Plan marketing strategies to increase company-specific sales

Team player, coordinating with co-workers and company clients

Ability to develop optimal strategic plans and follow through to success.

Work hard – play hard, win-win professional attitude to work.

Proficiency with Microsoft Office (PowerPoint, Excel, Word, and Outlook).

Eager to listen and learn.

Good interpersonal skills – Good skills in management and communication.

Responsible for formulation, direction and coordination of marketing activities and policies designed to promote company services, in coordination with relevant advertising and promotion managers.

Responsible for successfully aligning company objectives with customer’s goals.

Coordinated evaluation of different financial aspects such as expenditures and projection of profits or losses, budgets, returns on investments, etc.

SMC Medical Manufacturing and Pvt. Ltd., Bangalore, India

Title- Quality Analyst/Document Controller / Asst. Quality Manager.

Since January 2011 to July 2015.

Responsibilities

Document control:-

Main lead of document control through proper traceability and track down information.

Strong working knowledgne of an online Document Management system`

Controlling of Documents such as Maintaining in soft and hard copy with stamp of Master control & Obsolete copies.

Distributing the control copies of latest revision to relevant department according to distribution matrix.

Administers record, distribution, filing and archiving of all incoming and outgoing deliverables.

Assists Engineering team in the implementation of Document Control procedure.

Maintaining (DHR) Device history records and Product releases for each lot.

Document management system tracking of Drawings revision (Shop floor, proto design, Vendor & customer contract, Company confidential) etc..

Assistant Quality Manager & Internal Auditor:

Monitoring quality requirements in accordance with the company quality assurance policies and customer specifications.

Training contract / temporary employees in the Incoming inspection procedures, GMP (Good manufacturing practices), GDP (Good Documentation Practices), sanitation awareness, 5’s, 7 QC tools, FDA (Food and drug administration) awareness.

Conducting inspections at in-process, in-coming and completes the final inspections.

Accountable for performing accurate visual inspection of raw materials in accordance of COC (certificate of compliance), components, and sub-assemblies as per Inspection Plans and Specification Requirements.

Msaintaining inspection equipment and performing material kit audits to insure accuracy and integrity of the kitting process.

Working with other company personnel to resolve inspection questions. Communicate with project engineers to ensure schematics are in compliance with the final product.

Responsible for Third party audit ISO 9001:2008 & ISO 13485:2003 certification & internal auditing.

Conducting various tests and quality checks on finished products. ensure that all products have been tested and fall within standards, measured to specifications and within tolerances, readability of labels, etc.

Responsible for training on the procedures and Hygiene practices to the organization.

Maintaining Microbial record in ISO Class 7 and Class 8 as per procedure.

Creating Master documents to track Calibration and latest version of Documents and records.

Handled team of 6 to 8 people.

Prepared control plan, FMEA, Risk management documents.

Preparation of Dashboards and operational metrics trends.

Organizing Weekly review meeting and Management review.

Responsible of reporting 8D and Supplier CAPA.

Responsible for the new product development.

Responsible for vendor evaluation, selection Approval.

Managing customer requirement as per the procedure and norms.

Awareness on the Clean room class limits according ISO Standard 14644 also on ISO 14698 Clean rooms and associated controlled environments – Bio contamination Control

Chairperson for safety committee and arranging for proper PPE items.

Highlights

Headed audit ISO 13485:2003 and ISO 9001:2008 successfully for the organization and Implemented.

Participated in Validation activity as per GHTF (Global health task force) standard.

Prepared Validation protocol along with completion reports for assemblies and plastic molded parts.

Performed Minitab 16 for capability studies, Gauge R and R, Normality test, Probability plot, DOE,, Run charts.

Laxmi Electronics Engineering Pvt. Ltd., Karnataka Quality inspector September ’06 to December 2010

Project Handled

Project Title: OTIS Elevators, HP, SMC global (Medical Devices), and Schneider Electric project

Responsibilities

Incoming Inspection and entries accepted through SAP (QA) module.

Ensuring conformance to shippers or packaging sheet of all parts returned from customer or special performance by subcontractor.

Supervising transfer of discrepant material to quality control per aside for this purpose.

Inspecting sub-assemblies in accordance of print.

Schneider Electric. Pvt. Ltd., Nasik, Maharashtra Quality Engineer January ’04 to August 06

Project Handled: OTIS elevator, Mafelec Switches

Responsibilities

Inspecting sub-assemblies in accordance of print and any dimensional requirement.

Responsible for incoming Quality.

Responsible for Process inspection and Final Inspection.

Process inspection include- Soldering of PCB, Pad printing, Special test of torque to switches, etc..

Prepared inspection records and tracking of the defects per PPM level.

Satisfied customer for < 500PPM (Zero defects) and always meet the customer requirements.

Managed the project of 260 types of different Pushbutton.

Worked on lean line and implement Kanban system

Highlights

Customer satisfaction for < 500PPM.

Rishabh Instruments, Nasik, Maharashtra Quality inspector Jan 2003 to December 2003

Responsibilities

Responsible for Final and Process Quality.

Voltmeter sub assembly inspection for the coil and pointer.

Tracking the testing records and cosmetic inspection.

Flexibility of working in production and quality department.

CERTIFICATION COURSES

ISO 13485:2003 Internal auditor from UL India(Bangalore)

ISO 13485:2003 RABQSA Certified Lead Auditor from UL India (Bangalore)

ISO 14971:2007 Medical devices -- Application of risk management to medical devices UL India (Bangalore)

MSCIT -Maharashtra State - Certificate in Information Technology Computer knowledge

ISO IEC-17025 : 2005 Awareness & Internal Audit on calibration methodology from Transcal engineering India (Bangalore)

Basic training on AutoCAD from Aptech India (Bangalore)

Trained in Six Sigma green belt from Simpli learn India (Bangalore)

IRCA Approved ISO 9001 2015 Lead Auditor from 3 Fold institute (Dubai)

ACADEMIA

2013 Diploma in Mechanical Engineering from Karnataka Open University

2002 12th from B.Y.K College of commerce, Pune Board, Nasik, Maharashtra.

2000 10thfrom St. Lawrence high School Pune Board, Nasik, Maharashtra

Appreciation certificate for reviewing Engineering drawing (document control) in a timely manner

IT FORTE

Well versed with Microsoft office, Adobe Pdf, Microsoft picture manager, Minitab 16, SAP (Basics- QA Module) and Outlook express 2010.

EQUIPMENT HANDLED

Digital Vernier caliper

Micrometer

Height gauge

Pin gauge

Torque wrench

Particulate count

Air Velocity meter

Video measuring system

Moisture analyzer.

Thank you

Esha Vengurlekar

Contact this candidate