Vikas Bhagwat Email & Phone Number

Pune, Mh, In

Pune, Mh, In

Pune, Maharashtra, India

Pune, Maharashtra, India

• Ensures that appropriate quality plans are made that include all stages of the life cycle of the product and supports Quality Plan design.• Act as a single point of contact, responsible to ensure that hardware design meets quality and compliance standards for every milestone.• Validates key design inputs like usability, reliability, performance, supportability, manufacturability, localizability, safety, security, privacy, serviceability, sustainability, and costs.• Provides… Show more • Ensures that appropriate quality plans are made that include all stages of the life cycle of the product and supports Quality Plan design.• Act as a single point of contact, responsible to ensure that hardware design meets quality and compliance standards for every milestone.• Validates key design inputs like usability, reliability, performance, supportability, manufacturability, localizability, safety, security, privacy, serviceability, sustainability, and costs.• Provides effective oversight of the execution of the Quality Plan, any Risk Management activities, and of all design related activities during the product/system lifecycle.• Performs independent technical assessment on product quality performance and post-market product quality analysis.• Leads quality related problem solving and root cause analysis during design and manufacturing.• Uses post-market analytics and statistics to report on product quality performance in the field (provide feedback to manufacturing, suppliers, or design teams) and initiates field actions when required.• Ensures the DHF is adherent to the required processes & compliant throughout the project’s requirement PRP phases as documented in Project Plan.• Coordinating for project Stage reviews and Audits.• Actively participating in development process and the internal Audit. Show less

Ahmedabad, Gujarat, India

● Creating, Implementing, and managing robust quality management systems as per ISO 13485.● Creating, Implementing a risk management plan as per ISO 14971. Preparing risk assessment and control management documentation that apply to all phases of the life cycle of a medical device.● Preparing requirements traceability, generating trace matrix, and keeping track of requirements management tools such as JIRA by Atlassian and Greenlight Guru.● Overseeing all product development… Show more ● Creating, Implementing, and managing robust quality management systems as per ISO 13485.● Creating, Implementing a risk management plan as per ISO 14971. Preparing risk assessment and control management documentation that apply to all phases of the life cycle of a medical device.● Preparing requirements traceability, generating trace matrix, and keeping track of requirements management tools such as JIRA by Atlassian and Greenlight Guru.● Overseeing all product development procedures and identifying deviations from quality standards. Always be on the lookout for opportunities for improvement and developing new efficient systems.● System requirement writing, story writing concerning user needs, and keeping the record up to medical device life cycle.● Reviewing product requirements and ensuring that intended use, customer requirements, and regulatory requirements were addressed.● Ensuring design specifications, standards applied, and the result of the risk analysis present and maintained in the DMR file.● Working with third-party test labs for safety, EMI/EMC testing, packaging, handling, and environmental testing per reliability test plans.● Conducting internal audits and reviews regularly and ensuring that quality and compliance procedures are regularly followed. ● Keeping strong cooperation with hardware and software engineers● Supporting the creation of software and hardware requirements specifications, including traceability to system requirements.● Ensuring contract manufacturers driven to excellence in all aspects of manufacturing, involved in new product introduction and transfer.● Ensuring continuous production of advanced composite material and applications consistent with established standards, customer specifications, and project goals.● Coordinating with USA team members for quality and compliance-related policy setup.● Ensuring all sensitive and confidential information is handled appropriately. Show less

Ahmedabad, Gujarat, India

● Responsible for formulating, documenting, and maintaining quality standards and ongoing quality objectives and QMS as per ISO 9001 and ISO 13485.● Preparing and implementing quality training programs, looking for opportunities for improvement, and developing new procedures whenever required.● Analysing and extracting system requirements and generating a system requirement specification.● I am supporting electronics architecture design in agreement with system… Show more ● Responsible for formulating, documenting, and maintaining quality standards and ongoing quality objectives and QMS as per ISO 9001 and ISO 13485.● Preparing and implementing quality training programs, looking for opportunities for improvement, and developing new procedures whenever required.● Analysing and extracting system requirements and generating a system requirement specification.● I am supporting electronics architecture design in agreement with system requirements.● Responsible for product lifecycle management and traceability.● I am preparing Quality Assurance Plan for the company and Contract manufacturers.● Auditing contract manufacturers and verifying that they are following procedures as per QAP or not.● I coordinate quality objectives with the CMs team to maximize product reliability and minimize cost. ● Responsible for escalating technical issues to the design team, Providing feedback and customer suggestions to the product management team.● Jig, Fixture qualification, and concept.● Ensuring control of Inspection, Measuring, Test equipment, and calibration from a certified lab.● Responsible for supervising teams engaged in inspections and testing activities to ensure high productivity and technical integrity.● Analysis of raw material, In-process samples, and finished products.● Conducting quality management review and taking follow-up on action resulting from the study.● Ensuring documents and changes are approved before use.● Ensuring change records are reviewed and approved by the same functions that performed original review and approval.● Verifying DHRs maintained and devices are manufactured according to DHR, ensuring realization processes and products meet requirements. Show less

Bengaluru, Karnataka, India

● Quality validation and verification at various OEMs through defined standard quality requirements.● I am preparing an analysis of the non-conformance of the incoming, in-process, and final product.● Ensuring that all tests are done according to the approved sampling plan.● Ensuring a high level of internal and external customer service; investigating customer issues and complaints relating to quality.● I am doing surveys and selecting contract manufacturers for company… Show more ● Quality validation and verification at various OEMs through defined standard quality requirements.● I am preparing an analysis of the non-conformance of the incoming, in-process, and final product.● Ensuring that all tests are done according to the approved sampling plan.● Ensuring a high level of internal and external customer service; investigating customer issues and complaints relating to quality.● I am doing surveys and selecting contract manufacturers for company products.● Preparing and signing contract manufacturing agreement, Quality agreement with contract manufacturers.● Prospecting and interacting with suppliers to ensure the quality of the purchased product.● Handling cross-functionality and monitoring their performance for seamless quality work.● Contributing product preparation, repairs, Internal tests, External lab tests, and field trials and providing feedback to project managers.● I am writing and circulating Work Instructions, Installation Guides, Product SOP, Instruction for Use, Service Manuals to teams and customers as and when required. Show less

Pune, Maharashtra, India

● Managing customer service operations in the Pune region with 4-6 service engineers.● I am achieving the financial target by promoting annual maintenance contracts, CMC, spares, consumables, and accessories sales.● I am collecting market information on competitors’ customer-related information and utilizing it for company business development.● Providing technical service support to the customer. Taking responsibility for load studies, site studies, Installation, commissioning… Show more ● Managing customer service operations in the Pune region with 4-6 service engineers.● I am achieving the financial target by promoting annual maintenance contracts, CMC, spares, consumables, and accessories sales.● I am collecting market information on competitors’ customer-related information and utilizing it for company business development.● Providing technical service support to the customer. Taking responsibility for load studies, site studies, Installation, commissioning, preventive and breakdown service, service sales revenue, and customer satisfaction. Show less

Bachelor Of Electrical And Electronic Engineering, B+

Diploma In Electronics And Telecommunications, A