Ramkumar V Email & Phone Number

Bengaluru, Karnataka, India

Bengaluru, Karnataka, India

Bangalore, India

* QA Leader for Design & Development activities handling new product introduction (NPI) and design changes in ensuring effective implementation of QMS requirements.• Ensures quality and regulatory compliance in accordance with documented procedures and requirements• Developed, implemented, and continuously improved process effectiveness and efficiency in the modality and at site level.• Ensured process efficiency and compliance effectiveness• Support continuous product and… Show more * QA Leader for Design & Development activities handling new product introduction (NPI) and design changes in ensuring effective implementation of QMS requirements.• Ensures quality and regulatory compliance in accordance with documented procedures and requirements• Developed, implemented, and continuously improved process effectiveness and efficiency in the modality and at site level.• Ensured process efficiency and compliance effectiveness• Support continuous product and process improvement• Train engineering teams on compliance requirements, procedures and practices* Have been involved with various modalities like Maternal & Infant Care (MIC), Respirator products, ECG products, Monitoring solutions and X-Ray products in product development and IB support.* As QA of Core team, so far handled 7 NPI programs (End to end product development cycle) and 10+ IB products for post marketing support.* Handling FMI, Recalls, Product end of life cycle, Medical device reporting investigations and CAPAs* SME in Design controls life cycle, Risk Management, Post market (complaints handling), CAPA* Qualified Lead Auditor* Certified CSQE by ASQ* Lead Simplification Drive at the site and effectively implemented many simplification projects* Lead and institutionalized Site readiness to face inspection and audits Show less

Bengaluru Area, India

QA Lead Engineer for Design & Development activities handling new product introduction and design changes responsible toEnsures quality and regulatory compliance in accordance with documented procedures and requirementsImplemented, and continuously improved process effectiveness and efficiency in the modality.Maintain & keep quality procedures up to date and reflective of regulatory requirements. Represent QA on development projects and advise on the adequacy of validation of… Show more QA Lead Engineer for Design & Development activities handling new product introduction and design changes responsible toEnsures quality and regulatory compliance in accordance with documented procedures and requirementsImplemented, and continuously improved process effectiveness and efficiency in the modality.Maintain & keep quality procedures up to date and reflective of regulatory requirements. Represent QA on development projects and advise on the adequacy of validation of facilities, equipment and new products/processes Provide support to routine activities, projects, development and training relevant to area of expertise. Support the development and maintenance of Quality System metrics Supporting the preparation and execution of Quality Management Reviews at the site Analyze & communicate proposed, new or changing requirements Show less

Bangalore

In this role, Institutionalized Complaint Handling Unit (CHU) team for Ultrasound in Bangalore. Lead the CHU team in handling customer complaints for Ultrasound by receiving the complaints, assigning the owners, reviewing and approving the investigations and CAPAs, monitoring the effectiveness of the CAPA. Played the CAPA leader role for the customer complaints.Lead monthly internal Audit of Complaints globally across Ultrasound CHU teams. As part this role, monitored the product… Show more In this role, Institutionalized Complaint Handling Unit (CHU) team for Ultrasound in Bangalore. Lead the CHU team in handling customer complaints for Ultrasound by receiving the complaints, assigning the owners, reviewing and approving the investigations and CAPAs, monitoring the effectiveness of the CAPA. Played the CAPA leader role for the customer complaints.Lead monthly internal Audit of Complaints globally across Ultrasound CHU teams. As part this role, monitored the product performance in the installed base and reported out. Monitored the customer satisfaction and communicate the feedbacks to Installed Base Engineering team for preventive actions. Show less

Chennai Area, India

As Management Representative (MR) owned the responsibility of implementing medical device Quality Management System requirements at the site that performs Design controls, manufacturing, post market activities like design changes, complaint handling, CAPA etc. Responsible for Management controls, planning & leading Internal Audits and completing it, Handling External body audits.As QA Manager for the site, responsible for product quality from purchase control to incoming inspection to… Show more As Management Representative (MR) owned the responsibility of implementing medical device Quality Management System requirements at the site that performs Design controls, manufacturing, post market activities like design changes, complaint handling, CAPA etc. Responsible for Management controls, planning & leading Internal Audits and completing it, Handling External body audits.As QA Manager for the site, responsible for product quality from purchase control to incoming inspection to production testing to finished goods.In this role, lead the Quality team for implementing medical device requirements at the site by creating maintaining SOPs for incoming acceptance, inprocess and product testing and implementing it in manufacturing. During this period, also responsible to monitor the failure in manufacturing and drive CAPA as required to address the product quality issues at supplier end, manufacturing line and customer complaints.Drive process improvements. Show less

Madurai Area, India

QA Manager for Hearing Aid production. Responsible for product quality from purchase control to incoming inspection to production testing to finished goods. In this role, lead the Quality team for implementing medical device requirements in newly formed Hearing Aid manufacturing division by creating SOPs for incoming acceptance, inprocess and product testing and implementing it in manufacturing. Also responsible to monitor the failure in manufacturing and drive CAPA as required to address the… Show more QA Manager for Hearing Aid production. Responsible for product quality from purchase control to incoming inspection to production testing to finished goods. In this role, lead the Quality team for implementing medical device requirements in newly formed Hearing Aid manufacturing division by creating SOPs for incoming acceptance, inprocess and product testing and implementing it in manufacturing. Also responsible to monitor the failure in manufacturing and drive CAPA as required to address the product quality and process issues.Was certified lead auditor and won Best Internal Auditor award.Involved in initial design of Green Laser for Retinal treatment used in Ophthalmology. Show less

Bachelor Of Engineering - Be, Electrical, Electronics And Communications Engineering

Bachelor Of Engineering (B.E.), Electronics And Communications Engineering

Education record