Vikram Singh
Gurugram
Summary
With a proven track record at Degania Medical Devices Pvt Ltd, I leveraged my expertise in ISO 13485 and leadership abilities to enhance quality management systems, achieving significant improvements in compliance and process efficiency.
Overview
13
13
years of professional experience
1
1
Certification
Work History
Assistant Quality Manager
Degania Medical Devices Pvt Ltd
Gurugram
09.2022 - Current
- Developed and implemented quality management systems to ensure compliance with the ISO 13485 standard.
- Conducted internal audits of processes, products and services to identify areas for improvement.
- Analyzed customer feedback and complaints to determine root causes of issues and develop corrective actions.
- Monitored key process indicators related to quality objectives.
- Investigated nonconforming materials and products to identify root cause and implement corrective action plans.
- Reviewed existing QMS policies and procedures to ensure they are compliant with applicable regulations.
- Participated in design reviews for new products and processes, ensuring adherence to engineering standards.
- Trained and developed employees in effort to contribute to overall professional growth.
- Liaised with customers regarding product specifications, regulatory requirements, testing protocols.
- Maintained an up-to-date database of all customer complaints received from various channels.
- Actively participated in continuous improvement initiatives across the organization.
- Performed regular risk assessments on current processes and identified potential risks.
- Reviewed standard operating procedures or quality assurance manuals to refine production processes or update for conformity to new regulations or policies.
- Developed and maintained quality documentation, including quality manuals, procedures, and records.
- Negotiated quality agreements with suppliers and customers to clarify expectations and responsibilities.
- Established quality KPIs and reported on performance to senior management, highlighting achievements and areas for improvement.
Assistant Manager: Quality Control
Medico Electrodes International Ltd
Noida
12.2016 - 09.2022
- Handling overall quality control function: Supplier Quality, Process Quality, with a total team size of 30.
- Streamlining the Auditing Quality Management System as per ISO 13485: 2016 & Quality System Regulation (QSR) as per 21 CFR Part 820 Subchapter H
- To handle & assist external / internal audits and its associated records
- Overall preparation & control of Device Master Records (DMRs), Work Instructions (WIs) and Quality Procedures (SOPs)
- Responsible for control of monitoring and measuring devices.
- Review and Control of Process Validation Protocol, Stability Protocol, and Equipment Qualification Protocol (IQ, OQ, and PQ documents).
- To ensure that incoming, in-process, and finished-goods lot inspection records are completed timely and sharing rejection report along with data analysis on a daily, weekly, and monthly basis.
- Responsible for periodic monitoring of stability, control samples, and their documentation.
- Assisted in the development of operational strategies to ensure efficient and productive operations.
- Provided guidance and support to junior staff members on daily tasks, projects, and objectives.
- Conducted regular performance reviews for employees to identify areas of improvement.
Supplier Quality Engineer
C&S Electric Ltd.
Greater Noida
06.2014 - 11.2016
- To be performed quality inspection of the various parts including Sheet Metal, Casting, Forged components, machining parts etc
- Daily basis rejection analysis of NC material and to submit CAPA against identified NC
- Vendor Analysis by monitoring monthly QPR (Quality Performance Rating) & RR (Rejection Rating) records
- Conducted supplier audits to ensure quality standards were maintained.
- Reviewed supplier documentation and test reports to verify product conformity.
Engineer Trainee - Process Quality Control
ITC Ltd (Food Division)
Nadiad, Gujrat
01.2012 - 09.2012
- Detailed Learning: Knowledge of online quality checks in process area to ensure that all standards of quality are followed during the production process, to be identifying the HACCP & monitor the same
Education
B. Tech - Mechanical Engineering
ITS Engineering College
Greater Noida06-2012
Senior Secondary School Examination - Science, Mathematics
Dr Maria Res. Academy
Agra01.2008
Secondary School Examination -
Dr Maria Res. Academy
Agra01.2006
Skills
- Mechanical Engineering
- Medical Devices
- ISO 13485
- 21 CFR Part 820
- FDA
- 21 CFR Part 803
- Quality assurance expertise
- Supplier quality management
- Team leadership abilities
- Continuous improvement strategies
- Familiarity with quality standards
- Internal Auditing
- Team Training
- Manufacturing
- Quality Assurance
- Quality Control
- Supplier Quality Management
- Process improvement
- CAPA
- SOP
- Validation
- Change Management
- GMP
- QMS
- Quality Management Systems
- Regulatory compliance understanding
- Customer complaint handling
- ISO 9001
- Internal Audit
- Team Management
Certification
- Internal Audit Course on ISO 13485:2016, 2 days, Detailed understanding of ISO 13485:2016. Realize the true role & potential of internal QMS audits can plan & organize the internal audit. Be able to collect & analyze evidence, exercising objectivity. Know how to evaluate & report the results of an internal audit.
- Internal Audit Course on ISO 9001:2008, 2 days, Realize the true role & potential of internal QMS audits can plan & organize the internal audit. Be able to collect & analyze evidence, exercising objectivity. Know how to evaluate & report the results of an internal audit.
Projects
ITC Food Division, 2 months, Project to reduce cost of the Laminate in Cookies Line as it was very high and affecting total production cost. ITC Food Division, 2 months, Installation of Automated Fired System to minimize the Firing Time. Density Calculation & Analysis of individual material contributing in Biscuit Manufacturing for Proper Heat Distribution. 6 Weeks, Analysis has been done on the various graphs generated from output of a 'C++' Program, for calculating various factors such as work output, efficiency, and power loss with changing compressor ratio and Turbine Inlet Temperature.
Languages
Hindi
First Language
English
Upper Intermediate (B2)
B2
Timeline
Assistant Quality Manager
Degania Medical Devices Pvt Ltd
09.2022 - Current
Assistant Manager: Quality Control
Medico Electrodes International Ltd
12.2016 - 09.2022
Supplier Quality Engineer
C&S Electric Ltd.
06.2014 - 11.2016
Engineer Trainee - Process Quality Control
ITC Ltd (Food Division)
01.2012 - 09.2012
- Internal Audit Course on ISO 13485:2016, 2 days, Detailed understanding of ISO 13485:2016. Realize the true role & potential of internal QMS audits can plan & organize the internal audit. Be able to collect & analyze evidence, exercising objectivity. Know how to evaluate & report the results of an internal audit.
- Internal Audit Course on ISO 9001:2008, 2 days, Realize the true role & potential of internal QMS audits can plan & organize the internal audit. Be able to collect & analyze evidence, exercising objectivity. Know how to evaluate & report the results of an internal audit.
B. Tech - Mechanical Engineering
ITS Engineering College
Senior Secondary School Examination - Science, Mathematics
Dr Maria Res. Academy
Secondary School Examination -
Dr Maria Res. Academy
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