SURJIT SINGH Email: Surjitsingh1207@Gmail.

com
Address: # 154 Hill View Enclave, Dhakoli, Punjab (India) Mobile no: +91-7814157892

Professional Summary:
To further pursue my passion in Auditing, TCF review and in Medical device Industry and hone
my technical skills by applications that would be mutually beneficial to me as well as to the
industry.
Nearly 5+ year of experience as an external auditor in QMS Auditing and TCF Assessments
with Indian Certification Body (Zenith Quality Assessors Pvt Ltd) and as Executive regulatory
affairs & Internal auditor with an X-Ray Manufacturing Firm (Allengers Medical Systems Pvt
Ltd). Currently working as an Internal Auditor in IT Sector (Netsmartz).

 Lead Auditor  MDR (Course on  Indian MDR  Internal Auditor

Course on ISO MDR 2017/745) 2017 Course on ISO
13485:2016 & ISO  MDD to MDR Gap 13485:2016 & ISO
9001:2015 Course from BAI 9001:2015

Skills:

 Trained in QMS auditing and TCF assessment as per MDD 93/43/EEC.

 Trained in EU-MDR 2017/745 and Indian MDR 2017.
 Trained Lead auditor for ISO 13485 and ISO 9001 from Zenith Quality Assessors accredited
by ASCB-UK.
 Approved internal auditor for ISO 13485:2016 and ISO 9001:2015.
 Done Live project on ‘‘RADIATION SAFETY PROTOCOL FOLLOWED IN SUPER SPECIALITY
HOSPITAL’’ at Indus Super Speciality Hospital.
 Document Control System.
 MS Word, MS Excel, MS Power Point, E-draw Mind Map, Adobe Acrobat Professional &
Internet.
 Content Development & Database Administration.

Accomplishments:

 Under gone Training for Lead auditor course in ISO 13485:2016 and 9001:2015 from
Zenith Quality Assessors Pvt Ltd.
 Undergone internal auditor ISO 13485:2016, Risk Management and MDD training.
 Prepared and faced various international and national audits like ISO, CE and CDSCO etc.
 Industrial & Audit Experience: More than 5 years of expertise in Medical device industry
Auditing (ISO 13485) & Hospitals (ISO 9001).
Education:

 Post Grad in Hospital & Healthcare Management and Medico Legal System from Symbiosis
University (2015-16)
 Bachelors in Science (B.Sc.) in Biotechnology from Panjab University (2011-14)
 (10+2) in Medical from CBSE Board.

Work Experience:

Netsmartz, Chandigarh – Current

Role- Internal Auditor

Company Profile:
Netsmartz provides Enterprise application development, CRM implementation services, ERP
implementation services, Web application development, E-Learning and digital marketing
services, big data, Infrastructure and cloud services.

Roles & Responsibilities:

 Planning and conducting Internal Quality Audits for Organizational Projects based on CM
MI and ISO 9001 standards.
 Prepare SQA report for the findings during review.
 Performing Metric review and Data analysis for projects on monthly basis.
 Enabling and helping project teams in identifying project risks and planning mitigation a
nd contingency responses.
 Facilitating finding’s closer through proper root cause Analysis.
 Process Consulting to the Project Teams. Reviewing Project Management artifacts and p
roject’s progress.
 Facilitation of Software projects functional on development, maintenance, Agile, Staff A
ugmentation.
 Prepare SQA review plan for Projects and Functions.
 Follow up with all respective stakeholders for Quarterly MRM meeting as per agenda.
 Responsible for conducting SQA audit for project as per schedule in SQA Plan.
 Prepare Annual and Monthly Internal audit plan for Projects and Functions
 To conduct audit as per Internal audit plan with Team leads.
 Prepare report and send to the respective stakeholder after reviewing with Team lead
 Prepare Monthly ASR (Audit Summary Report)
 Update processes as per the Changes in the activities and Change request
 Participate in the External audits along with team for CMMI and ISO 9001.
 To provide inputs for QA and SEPG schedule meeting presentations.
 Follow up with all respective stakeholders for Quarterly MRM meeting as per agenda.
 Process moderator for Sales Meetings
Zenith Quality Assessors Pvt Ltd, Pune (2019- 20)
Role- QMS Auditor & Product assessor

Company Profile:
ZQAPL provides Audit, Certification, Public Training and GHG verification and validation
Services to organizations.
The Management Systems Audit and Certification Activity of ZQAPL consists of a series of
activities aimed at assessing the capability of an organization’s management system such as:
 ISO 9001 Quality Management System
 ISO 13485 Medical Devices - Quality Management System
 ISO 14001 Environment Management System
 OHSAS 18001 Occupational Health & Safety Management System
 ISO 45001 Occupational Health & Safety Management System
 ISO 22000 Food Safety Management System
 ISO 27001 Information Security Management System
 ISO/TS 16949 Quality management systems - Particular requirements for the application
of ISO 9001 for automotive production and relevant service part organizations
 ISO 20000 Information technology -- Service management
 ISO 20252 Market, opinion and social research - Vocabulary and service requirements
 ISO/TS 29001 Petroleum, petrochemical and natural gas industries–Sector specific quality
management systems
 ISO 10002 Quality management -- Customer satisfaction -- Guidelines for complaints
handling in organizations and CE Marking for various products under applicable EU
Directives GHG verification and validation activities

Roles & Responsibilities:

 To conduct Quality Management System audits ISO 9001 & ISO 13485
 To conduct Product Certification audits for CE mark certification for medical devices
 To conduct review of Technical constructions file/s (TCFs) & Design Dossier/s (DDs) for
medical devices
 To review Quality manual, Quality System procedures & other document which are
mandatory for certifying particular organization.

Allengers Medical systems Ltd. (2015-19)

Role- Executive Regulatory Affairs

Company Profile:
Manufacturers and exporters of a wide range of medical diagnostic equipment comprising X-
ray systems, Digital Radiography systems, DSA systems, C-Arms, Cath Labs, and Remote
controlled RF table, Mammography, Lithotripters, OPG, MPM, ECG, EEG, EMG, PSG, Holmium
Laser Etc.
Roles & Responsibilities:
 Coordinate & Execute External Audits.
 Closing of non-conformities & Implementation of CAPA
 Conduct IQAs in compliance with ISO 13485 & 9001
 Identifying the gaps & risks involved in the processes.
 Monitor the effectiveness of QMS processes.
 Ensures compliance with established internal control procedures by examining records,
reports, operating practices & documentation.
 Handle customer audits.
 Update Quality Manual & its documentation in accordance with latest guidelines.
 Manage & Review Document Control in accordance with ISO 13485 & 9001.
 Review TCFs/MDFs ensuring compliance to applicable standards.
 Impart induction trainings for ISO 13485/9001 & Process risks.
 Assist in driving regulatory submissions.
 Review post-production database to see level of customer focus.
 Provide Post-Market support for approved Class IIB and 510(k) products.
 Update IFUs and labels to meet FDA and CE requirements.
 Work on floor issues, identify RCs & CAPAs.
 Review KPIs to measure process effectiveness.
 Provide regulatory support for new products and modifications to existing products.
 Perform all other jobs as per exigency of work delegated.

Personal Information:
 Nationality: Indian
 Date of Birth: 12/07/1993
 Father's Name: Sh. Rajesh Kumar
 Languages Known: English, Hindi, Punjabi

Declaration:
I hereby declare that all the above information is true to the best of my knowledge.

Surjit Singh