CAREEER OBJECTIVE

KOUSHIK 0
NATH
Senior Quality ENGINEER
PROFILE
B.Tech Mechanical Engineer and
Certified ISO Auditor presently
employed as Senior Quality
Engineer for Complaints Handling
and Regulatory Reporting of
Medical Devices with eight years
of experience in QA, QC, TQM,
ISO Audits, Medical Device
Regulatory Reporting, Quality
Management System, Complaints
Management System in search of a
challenging opportunity.
To further enhance my technical, managerial and ethical knowledge and hence
nurture my own skills to propel my career towards my goal of being a successful
quality technical individual.
Abridgement:
1. Completed B.Tech in Mechanical Engineer from Sikkim Manipal Institute of Technology
2. Certified Lead Auditor for ISO 9001.
3. Presently working for Kritikal Solutions as a Senior Quality Engineer - Complaints
Handling and Regulatory Reporting of Medical Devices since 2017.
4. Worked for IQuest Consultants as a Senior Quality Engineer - Complaints Handling and
Regulatory Reporting of Medical Devices for two and a half years.
5. Worked for KVQA Certification Services as a ISO Technical Auditor for ISO 9001,
14001, 18001, 13485 standards for 1 year.
6. Worked for Nextgen Printers Pvt. Ltd as a QC & QA Supervisor and Management
Representative for ISO 9001, 18001, 14001 standards for 3 years.
7. A focused and hardworking professional with more than 6 years of experience in Medical
Devices Regulatory Reporting, Complaints Management System of Medical Devices,
documentation/implementation/sustenance of Quality Management System, Post Market
Product Surveillance, Safety Management System, Environmental Management System,
ISO Standards, QA, QC, CAPA, TQM, FMEA, DFMEA, FMECA, FTA.

CONTACT ME
Core competencies:
+91 - 9873865503 1. Possesses profound practical and theoretical knowledge about the best prctices and lean
principles of TQM (Kaizen,5 S, 5 Why, Fishbone or ISHIKAWA diagram, Poka Yoke,
koushik.nath1@gmail.com FMECA, FTA, CAPA, PDCA cycle, 7QC Tools, 8D problem solving and other QA &
QC practices).
Flat No 319, Mahagun
Villa, Vaishali, Ghaziabad, 2. Possess practical and theoretical knowledge about ISO 9001, ISO14001, ISO18001,
Uttar Pradesh-201010. ISO22001, ISO13485, TS16949 standards and their documentation.
3. More than 8 years of experience in documentation/implementation/sustenance of Quality
Management System, Compliant Management System, Safety Management System,
Security & Environmental Management.
4. Proficient in grasping new technical concepts quickly and utilizing it in a productive
manner.
5. An effective communicator with strong analytical, logical, interpersonal skills and an
PERSONAL SKILLS ability to work effectively in fast paced environment identifying areas of obstruction and
taking steps to rectify through application of trouble shooting methods.
Team Work 6. Coordinating with the other departments for smooth functioning and accomplishing
Analytical Skill production as per customer’s requirement & organizational guidelines.
Self-Motivated
Adaptability
Leadership
Communication
Adventurous
Co-ordination
Logical Skill
 0
EXPERIENCE
Jan’17 – Present
Senior Quality Engineer – Kritikal Solutions.
CONNECT ROLE AND RESPONSIBILITIES.
Implementation & Sustenance of Complaints Management System, Regulatory
https://www.linkedin.com/feed/ Reporting and Quality Management System for
?trk=nav_logo Client Organization (Stryker Global Research Center).
1. To generate “product complaint trend analysis” requests.
https://my.naukri.com/Hom 2. To conduct full scale trend analysis and publish memorandums of trend analysis reports
ePage/view
for products against whom product complaint trend analysis requests have been received.
https://www.facebook.com/ 3. Perform root cause analysis to identify any possible Non Conformity.
knbtechme 4. To prepare and apply appropriate CAPA (Corrective & Preventive Actions) for any
identified NC (Non Conformity).
5. To conduct quarterly product complaint trend analysis on catalog numbers/product family
of medical instrument/medical implants against whom trend analysis requests have been
received.
6. Responsible for receiving, reviewing, and entering data into the Compliant Management
Database regarding customer product inquiries and complaints using good documentation
practices (GDP).
7. To conduct full scale investigations on received complaints by performing Product
LANAGUAGES
Identification, Product Inspection, Product History Review, Complaint History Review,
NC/CAPA History Review, Labelling Review, Additional Document Review, Risk
ENGLISH Assessment and provide a precise and accurate conclusion and assign appropriate Product
Problem Codes.
HINDI 8. To perform regulatory review by determining the received complaint’s reportability to
Assamese Regulatory agencies.
9. To report complaints received from United States to FDA via Electronic Medical Device
Bengali Reporting (eMDR) as per 21 CFR 820.
10. To report complaints received from countries like France, Italy, England, Japan, China,
Nepali
Australia, Canada etc to their respective Regulatory Agencies like ANSM, MHRA, TGA,
PDMA etc via Electronic Medical Device Validation (eMDV).
11. Work in a matrix organizational structure to coordinate and gather relevant information
regarding customers/users/products against whom complaints have been received, from
departments like Regulatory, Material Analysis Engineering, Medical Review Panel,
Legal Team/Attorneys, Outsourced Call Centers, Doctors and Sales Rep and also from
databases of Manufacturing Records, Previous Complaint Records, Product Design,
Product Risk Analysis documents like FMEA, DFMEA, FMECA, FTA etc.
May’2014 – Dec’2016
Senior Quality Engineer – IQuest Management Solutions.
ROLE AND RESPONSIBILITIES.
Implementation & Sustenance of Complaints Management System, Regulatory
Reporting and Quality Management System for
Client Organization (Stryker Global Research Center).

1. Responsible for receiving, reviewing, and entering data into the Compliant Management
Database regarding customer product inquiries and complaints using good
documentation practices (GDP).
2. To conduct full scale investigations on received complaints by performing Product
Identification, Product Inspection, Product History Review, Complaint History Review,
NC/CAPA History Review, Labelling Review, Additional Document Review, Risk
Assessment and provide a precise and accurate conclusion and assign appropriate
Product Problem Codes.
3. To perform regulatory review by determining the received complaint’s reportability to
Regulatory agencies
4. To report complaints received from United States to FDA via Electronic Medical Device
Reporting (eMDR).
5. To report complaints received from countries like France, Italy, England, Japan, China,
Australia, Canada etc to their respective Regulatory Agencies like ANSM, MHRA,
TGA, PDMA etc via Electronic Medical Device Validation (eMDV).
6. Work in a matrix organizational structure to coordinate and gather relevant information
regarding customers/users/products against whom complaints have been received, from
departments like Regulatory, Material Analysis Engineering, Medical Review Panel,
Legal Team/Attorneys, Outsourced Call Centers, Doctors and Sales Rep and also from
databases of Manufacturing Records, Previous Complaint Records, Product Design,
Product Risk Analysis documents like FMEA, DFMEA, FMECA, FTA etc.
7. To send the medical reports and X-rays received from complainant, sales representative
& hospital to empaneled clinical consultants for a medical review.
8. To send material analysis report requests to lab technicians on medical implants &
medical instruments which have been returned by complainant & hospital.
9. To coordinate with the legal team for receiving and updating information on cases
against which legal proceedings have been started by the complainant.
Feb’2013 – Apr’2014
Technical ISO Auditor – KVQA Certifications.
1. To perform ISO 9001,14001,18001, TS-16949, 13485 management systems
documentation for client organization as per the audit pre-requisite criteria.
2. To conduct both initial and surveillance audits of ISO 9001,14001,18001, 13485,
TS-16949 standards on client organizations.
3. This entails verifying and updating all quality records, Scope Identification, GAP
Analysis, Development of Policy Documents, Quality Manual & SOPs. User
Awareness Trainings, Assets Identification and Classification, Risk Assessment,
Development of Procedures and Process documents, Control Implementations,
Conducting Internal Auditor Training Programs, Review Implementation
implementing ISO related quality records and activities, managing internal audit, as
well as creating awareness of ISO culture in the company at all levels.
4. To verify if the proposed CAPA for the existing non conformities are effective
enough and in case of deficiency suggest efficient and proper CAPA to the MR of
the client organization.
5. To verify Internal Quality Audits and MRM i.e Management Review Meeting
reports of client organizations and report their status to the certification committee.
6. To verify if the process approach, list of work instructions and list of records,
policies, modules, pre requisite programs, critical control points, planning
maintained for the proper implementation of different ISO standards are effective
and conform to applicable standards.
Oct’2010 – Feb’2013
Quality Supervisor & Management Representative (MR) for
ISO 9001, 14001 & 18001 – Nextgen Printers Pvt. Ltd.
Implementation & Sustenance of Complaints Management System/Quality
Management System of Pharma Products & Medical Device Packaging
Department.
1. To plan and implement lean principles of TQM like Kaizen, 5 S etc in the entire plant.
2. To manage & handle all types of customer complaints.
3. To manage quality, safety, security & environmental management systems
documentation for the entire plant and keep all documents up-to-date and under control.
4. To conduct Internal ISO internal audits and Management Review Meetings as per the
planned schedule.
5. Documentation, Implementation & Sustenance of ISO Manuals, Standard Operating
Procedures, Good Manufacturing Practices, Preventive Maintenance Schedules and
Safety Precaution.
6. To plan, monitor and measure the performance of the daily production on ERP.
7. To monitor and give feedback on certificate of analysis (COA), acquired quality level
(AQL) and other quality records for all incoming and outgoing goods.

EDUCATION

6.04 CGPA BACHELORS OF TECHNOLOGY in MECHANICAL ENGINEERING

from Sikkim Manipal Institute of Technology (Majhitar, Sikkim, India)

57.8 % INTERMEDIATE In SCIENCE from Darrang College(Tezpur, Assam,

India).

64.33 % MATRICULATION from Don Bosco School (Tezpur, Assam, India).

DECLARATION
The above-mentioned information is correct to the best of my knowledge and I bear the
responsibility for its authenticity.