SHAMBHU KUMAR SINGH
QUALITY ENGINEER
Sonipat
Summary
To be the part of an organization that provides an opportunity to utilize skills, improve knowledge with latest trends and to be a part of the team that works dynamically towards the growth of the Company/Institution.
Quality assurance professional with proven track record of enhancing product reliability and streamlining processes. Known for strong focus on team collaboration and achieving consistent results while adapting to evolving project demands. Skilled in root cause analysis and continuous improvement methodologies, bringing reliability and integrity to every task.
Overview
4
4
years of professional experience
4
4
Certifications
1
1
Language
Work History
Quality Engineer
M/S Prime Healthcare Products Pvt. Ltd.
10.2021 - Current
- Responsible for implementation of Quality Management System as per ISO 13485 and Medical Device Rule 2017.
- Monitor production conformance with QA standards and procedures.
- Responsible for process validation (IQ, OQ & PQ). Ensuring revalidation of process.
- Sterilizer validation (EO) and operation of HVAC validation. Ensuring revalidation of sterilizer.
- Ensuring timely calibrations of instruments/ equipment and compilation of calibration certificates in close coordination with Quality Control.
- Ensuring that Change Control process is followed for all material, process & product related changes.
- Manage time to time submission of regulatory applications dossiers that pertain to Registration, Manufacturing License, Test License, Non-Conviction Certificate, Free Sale Certificate and New Medical Device Manufacturing License for Medical Devices to the competent authority i.e. Drug controller General of India office/CDSCO through Portal Online/offline mode.
- Maintaining Quality record - issuance of logbooks, formats, Batch Manufacturing Record and all other controlled documents as per requirement.
- Maintaining Quality Management System documentation as per standard/ guideline requirements.
- Responsible for all external and internal audits (including conducting internal audits, managing external audit schedules, directly facing auditors during Regulatory Agency audits, and corresponding with Regulatory Agencies on audit findings and closure)
- Monitoring and Ensuring compliance of product labeling and marketing materials.
- Responsible for Supplier Evaluation & Qualification, supplier audits, and ensuring the Approved Supplier List updated and maintained.
- Handling of Change Control, Handling of deviation, and Handling of Non-conformance.
- Ensure continuous process improvement through effective implementation of organizational Quality Management System (QMS).
- Internal audits as per scheduled calendar-ensure execution, process & implementation of departmental internal audits. Timely closure of identified nonconformities & implementation of taken corrective & preventive actions.
- Department Reviews & ensure compliances in respect to ISO 13485 & QMS requirements.
- Handling Customer Complaint documentation; receipt till closure and maintaining complaint log.
- Assist in updating of Technical files as per requirements.
- Preparation and compilation of SOPs, WIs & Quality formats related documentation.
- Assisting in closure on NC and CAPA raised from external/ internal audits.
- Assisting in organizing & documenting so monthly MRM and internal audit documents as per requirement.
- Conducting shop floor training as per Quality training calendar and maintaining records.
Education
M.Tech. - Mechanical
Kurukshetra University
Ambala, Haryana01.2020
B.Tech. - Mechanical
Kurukshetra University
Dheen (Ambala), Haryana01.2017
12th -
B.S.E.B Patna
Khajedih, Madhubani01.2013
10th -
Bihar School Examination Board, Patna
Khajedih, Madhubani01.2011
Skills
Proficient in MS Office (MS Word, MS Excel, MS PowerPoint and Internet Applications)
undefinedInterests
Gardening, Playing chess & Badminton, Net Surfing, Reading Book, Listening Music
ACHIEVEMENTS/ EXTRA CURRICULAR ACTIVITIES
Active member in all symposiums conducted by our department. Awarded for Academic excellence. Got Full marks (100 out of 100) in Fluid Machines in B.Tech (5th sem). Actively participated in Technical Seminars, cultural programs, group discussions.
INDUSTRIAL TRAININGS/WORKSHOPS
- Organization: Pasco Motors, Dosarka, Ambala Duration: 27th June 2015 to 24th July 2015 Knowledge Gained: Learnt about automobile
- Organization: Cad Cam Technologies, Ambala, Haryana Duration: 04th July 2016 to 20th August 2016 Knowledge Gained: Learnt about computer based design.
DECLARATION
I hereby declare that the above mentioned information is correct up to my knowledge and I bear the responsibility for the correctness of the above mentioned particulars.
STRENGTHS
- Ability to work with team as well as individual.
- Easily adaptable to working environment.
- Dedicated towards work assigned.
- Positive attitude and self-motivated.
Certification
Risk Management for Medical Devices (ISO 14971:2019)
Timeline
ISO 13485 Lead Auditor
10-2025
Risk Management for Medical Devices (ISO 14971:2019)
09-2025
Internal Auditing for Quality Management System for Medical Devices based on ISO 13485:2016
06-2024
Quality Engineer
M/S Prime Healthcare Products Pvt. Ltd.
10.2021 - Current
B.Tech. - Mechanical
Kurukshetra University
M.Tech. - Mechanical
Kurukshetra University
12th -
B.S.E.B Patna
10th -
Bihar School Examination Board, Patna