CURRICULUM VITEA

Md. NAUSHAD RAINI

Contact No.: +91-8005761565, +91-9456676776
Whatsapp:- +91-9456676776
E-mail Id: naushadahmad40@yahoo.com
naushadk34@gmail.com

Present add- RIICO chowk Bhiwadi, Alwar Raj. (India)

Quality Assurance System/ Quality Management System

EXECUTIVE SUMMARY

➢ An astute professional with 11+ years of rich and insightful experience in operations,
Quality Assurance.

➢ Associated with Paramount Surgimed Limited

➢ Designing Systems and implementing processes that will enable organization to

consistently meet and enhance customer satisfaction.

➢ Experience in analyzing various processes/ applications and recommending process

modifications to enhance operational efficiency.

➢ Experience in world wide MOH registration.

CORE COMPETENCIES

Quality Assurance ~ Quality Control ~ Organized 4-Level of Documentation

EDUCATION

2004 B.Sc. – From University of Allahabad

Regulatory Certification: 1. Certified as Internal auditor for ISO 13485:2003/ EN ISO
13485:2012 by Det Norske Veritus.

2. Certified as Internal auditor for ISO 13485:2016 by PRESFAE

DNV GL NEMKO

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IT Skills- Well versed with MS Excel, MS-Word, MS-Power point and E-mail and Internet Etc.
Develop, document and implement Quality Management Systems (ISO 13485:2016) within the
organization for e.g. Documentation of

➢ Quality Manual: Quality policy, Quality Objective

➢ Quality System Procedures: All six mandatory procedures.

• Control of documents
• Control of records
• Internal audit
• Control of non-conformities
• Corrective action
• Preventive action

➢ Work Instructions, SOPs: Specifications, Machine manuals, Inspection and process

standards etc.

➢ Formats and records according to use.

➢ Vendor evaluation, assessment and approval and audit reports.

➢ Developing C.A.P.A system of non conformance.

➢ Developing “Change-Control” System

➢ Developing Risk Management File as per EN ISO 14971:2012.

➢ Developing Clinical evaluation as per MEDDEV 2.7.1 Rev4 of MDD 93/42/EEC.

➢ Developing documentation as per guidelines of EU MDR and FDA (21CFR parts 210,
211 and 820).
➢ Classification of medical devices as per MEDDEV 2.4.1 Rev9 of MDD 93/42/EEC.

➢ Preparing schedules for internal audits and ensuring implementation as per quality
standards.
➢ Responsible for handling ISO 13485 audit and preparing their CAPA compliance.

➢ Report to top management on the performance of the QMS (e.g., results of quality audits,
corrective actions), including the need for improvement.

➢ Ensure that the organization’s Quality Management System conforms to customer,

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 internal, ISO 13485:2016 and MDD 93/42/EEC.

➢ Provide trainings in the organization to all concerned persons on relevant subjects.

VALIDATION
Validation as per FDA & EU guideline including…

➢ Design qualification
➢ Installation qualification
➢ Operation qualification
➢ Performance qualification
➢ All above qualification reports
➢ Process Validation
➢ Product design verification & Validation

QUALITY ASSURANCE

➢ Providing assistance in quality assurance at various points in manufacturing process,

finished goods & investigation of defects & assistance in solving quality problems during
production.

➢ Managing material rejection and providing feedback on manufacturing defects.

CAREER COTOUR

a)
May 2018 to till date : Paramount Surgimed Limited
Designation: Manager Quality Assurance (RA)
Industry: MFG Sector- Medical Devices (Surgical
Blade)
Location: Bhiwadi Rajasthan
Handling: QA RA
b)
Aug 2017 to April 2018 : Disposafe Health and Life Care Limited.
Designation: Assistant Manager Quality Assurance
Industry: MFG Sector- Medical Devices
Location: Faridabad Haryana
Function Handling: QA RA
b)
July 2016 to July 2017 : Geemed Healthcare
Designation: Quality Head
Industry: MFG Sector- Medical Devices
Location: Ghaziabad Uttar Pradesh
Function Handling: QA RA
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 c)
NOV 2012 to June 2016 : LIFELINE SYSTEMS PVT. LTD.
Designation: Assistant Manager Quality Assurance
Industry: MFG Sector- Medical Devices
Location: Bhiwadi Rajesthan
Function Handling: QA RA

d)
MAR- 2007 to OCT 2012 : M/S VITROMED HEALTH CARE.
Designation: Sr. QA Executive
Last Industry: Mfg. Sector –Medical Device
Location: Jaipur Rajesthan

PERSONAL DETAILS

Permanent Address: Vill. + Post – Bara Bazar,

Dist. Ghazipur U.P. 232325

D.O.B. : 05/02/1984

Md. Naushad Raini

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