Goal-oriented professional with nearly 13 years of experience in Quality Management, specialising in the full product lifecycle of medical devices. Expertise includes design management, product testing, engineering change management, SaMD, SiMD and manufacturing quality assurance, all while ensuring compliance with FDA regulations such as 21 CFR 820 and 21 CFR Part 11. Proven ability to provide technical leadership and guidance, effectively plan and schedule tasks, and collaborate with cross-functional teams to monitor project progress and uphold quality standards. Strong communicator with exceptional analytical, coordination, and relationship management skills, dedicated to fostering a collaborative team environment that drives success and innovation.
Hi, I’m
Sridhar K
Quality Professional
Bengaluru
Summary
Overview
13
years of professional experience
1
Language
Work History
GE Health Care
Senior Quality Lead Specialist
05.2022 - Current
Job overview
- Led quality team in Digital Healthcare to support design and development through to market launch of medical device software.
- Managed total quality management system for business.
- Optimized process effectiveness, upholding quality compliance.
- Conducted investigations to develop and implement effective solutions for product and process corrections, retrospective and remediation action plans.
- Developed detailed QMS documentation, including quality system manual, SOPs, work instructions, forms, and reports.
- Implemented internal audits to uphold quality standards across multiple modalities.
- Conducted management review meetings in accordance with established procedures.
- Streamlined processes for internal and external audits to minimize discrepancies.
- Prepared and reviewed documentation during design and development stages for 510k submission.
- Developed strategies for tracing latest revisions of CSV tools across individual programs.
Philips Health Care
Senior Quality Engineer
07.2021 - 04.2022
Job overview
- Lead the quality team for Radiology Informatics to support Design, Development till launch to market of the medical device software’s.
- Ensures the seamless operation of all medical software solutions, including patient apps, clinical databases, customer relations management systems, and medical equipment software.
- Assisted developers in readiness for compliance testing with key regulatory frameworks.
- Review and provide technical & quality comments on the deliverables to ensure correct documentation.
- Demonstrated proficiency in initiating design to production trials.
- Streamlined processes to achieve timely completion without compromising quality.
- Successfully achieved all the milestones on time as per project and launched all software products on time.
Larsen & Toubro Pvt Ltd
Senior Engineer
09.2019 - 06.2021
Job overview
- Design History file remediation.
- Coordinate with other functions (Product Manager / Marketing, QE, RA, and Clinical Affairs) to develop, evaluate, review and approve risk management files as a part of DHF Remediation activity.
- Develop risk management documentation based on accurate technical product information, implementation of design, manufacturing, and installation.
- Perform risk evaluation activities and determination of risk estimation as part of risk management based on post-production and post-commercialization monitoring.
- Ensure that the information within the RMF is complete and accurate, and contains all applicable control measures, RBA’s, and verification evidence.
- Interacting with medical team, technical operations, regulatory, quality, etc. for gathering the inputs.
- Conducting a formal design/phase review at the conclusion of each milestone or phase in order to assess that deliverable have been addressed.
- Review and provide technical & quality comments on the deliverables to ensure correct documentation
- Performed as a cross functional team member and enabled regulatory team to submit the 510(K) submission.
- Successfully solved major quality issue of the project.
HCL technologies Pvt Ltd
Lead Engineer
03.2014 - 09.2019
Job overview
- Design history file remediation and testing.
- Developing test methods, writing quality test procedures, and checking quality to ensure compliance
- Planning and implementing quality testing procedures, scheduling project plans, and preparing documents.
- Guiding quality assurance engineers in IQ/OQ/PQ activities and validation.
- Performed root cause analysis of failures in mechanical parts.
- Executing validation activities as well as provide support to the staff to achieve the milestones.
- Applied knowledge on methodologies of verification & validation, FDA (21CFR803/806/820).
- Test protocol, test execution & test report preparation for verifying the feasibility of the change.
- Provided effective support in all the stages of product development by applying quality engineering applications
- Coordinated with the team to develop and review Hazard analysis, user error risk analysis.
- Performed verification & validation studies.
- Conducted design standards review.
- Developed customized test equipment’s for testing.
- Responsible for the PLM approvals (Quality) of the documents.
- Review the Preliminary Hazard Analysis, Complaints Analysis, and Design Failure Mode and Effect Analysis.
- Resource planning and training.
- Mentor the team members on creating the documents for DHF.
- Review the User Needs Document, Design and Development Plan, Project Request Form, and Design Control Traceability Table complying with Quality System Procedure.
- Implemented an approach to perform validation test of the device in-house to avoid the laboratory cost for the customer. Later on, this approach continued in multiple programs, which expanded the usage of in-house laboratory low-to-medium 45%
Karnataka Turned Components Pvt Ltd
Quality Executive
01.2013 - 02.2014
Job overview
- Plant quality management support and process documentations and approvals
- Performed gauge R&R studies.
- Implemented quality matrix and maintained for individual product line.
- Responsible to ensure supplier quality audit and documentation.
- Responsible for shop floor inspections.
- Handled clean room equipment’s CMM, surface tester, roundness tester.
- Study and understand Corrective and Preventive actions at client which is used to identify and implement the changes necessary to maintain continued stability, adequacy and effectiveness QMS as well as Medical device safety and performance
- To evaluate and identify any gaps within CAPAs in scope, to assess any additional investigational requirements and/or correctives actions and remediate each CAPA record (as needed) with identified actions to adequately close in a timely manner.
- Work with each CAPA Owner on the gaps identified and subsequent updates to CAPA Documents based on the discussion with individual CAPA Owners
Education
Bharath UniversityChennai, Tamilnadu
Bachelor of Engineering from Mechanical Engineering
University Overview
RVS Polytechnic CollegeDindigul, Tamilnadu
Diploma from Mechanical Engineering
University Overview
Skills
Quality System Management
KNOWLEDGE PURVIEW
KNOWLEDGE PURVIEW
- Handling requirement gathering, system analysis and finalization of technical / functional specifications and high level design documents for the project.
- Technical expertise in Product Testing entailing requirement analysis, design, Test Cases generation and Implementation testing.
- Ability to ensure that the product development projects and changes to existing products are conducted in compliance with FDA quality system.
- Ability to create protocols for verification and validation tests, SOP’s and Work Instructions.
- Customer coordination and working closely with the project team (DEV, QA, and PM)
- Proficient in handling quality of release for delivering the required output in a very systematic way.
- Able to quickly adopt and well versed in new areas (Technologies, Tools).
- Ability to handle multiple priorities and manage within deadlines.
- Ability to analyse new functionality and identify potential areas of impact.
Timeline
Senior Quality Lead Specialist
GE Health Care
05.2022 - Current
Senior Quality Engineer
Philips Health Care
07.2021 - 04.2022
Senior Engineer
Larsen & Toubro Pvt Ltd
09.2019 - 06.2021
Lead Engineer
HCL technologies Pvt Ltd
03.2014 - 09.2019
Quality Executive
Karnataka Turned Components Pvt Ltd
01.2013 - 02.2014
Bharath University
Bachelor of Engineering from Mechanical Engineering
RVS Polytechnic College
Diploma from Mechanical Engineering
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