Tejasree Yenigalla
Valley cottage,NY
Summary
Seasoned Quality Lead with a robust history at Innovative Health Sciences, adept in Quality Management Systems and strategic planning. Excelled in enhancing product quality and regulatory compliance, leveraging expertise in FDA 510K submissions, oversees Quality operations throughout the production. Proven track record in leading successful audits and driving significant process optimizations, demonstrating exceptional leadership and analytical skills.
Overview
11
11
years of professional experience
1
1
Certification
Work History
Quality Lead/Regulatory (PRRC) / Management Representative
Innovative Health Sciences
New York
05.2022 - Current
- Lead, manage, or oversee the Quality Assurance Department in all efforts of quality and safety. Develop, implement, and manage processes to ensure that products (Insignis Infusion System and IV infusion) meet required specifications for quality, function, and reliability prior to delivery.
- As a Quality Lead and Person Responsible for Regulatory/Compliance (PRRC), I manage all internal quality operations, quality audits, and provide quality support to multiple departments, such as product development, design, manufacturing, testing, packaging, and labeling.
- As a Subject Matter Expert (SME), review and approve the Master Design Validation Plan and Reporting (DVP&R), and oversee the implementation of product validation activities.
- Responsible for maintaining and updating Design History Files (DHF), Device History Records (DHRs), and Technical File documentation.
- Responsible for internal and external quality audits, such as ISO 13485, IEC 62304, CE under MDD/MDR, MDSAP, microbiology audits, and part of the FDA 510(k) submission for the product.
- Lead all the activities, including scheduling, conducting, developing audit plans, preparing documentation, and reporting all follow-up activities if any non-conformances are found.
- As regulatory personnel, provide and update regulatory information on product development and planning throughout the product life cycle, and interact with distributors to work on different country registrations all over the world, including all European countries, the Middle East, Asia, and Central America, to register the product in accordance with regulatory compliance.
- Work with the Supplier Quality team in supporting the final product release from the supplier. Manage, monitor, and improve supplier supply chain performance through supplier qualification and supplier evaluations, and ensure the highest quality standards are applied to raw material purchases and product manufacture at the supplier site.
- Interacts with multiple teams to develop and deliver the product acceptance sampling strategy, the Approved Supplier List (ASL), and maintain supplier Quality Agreements and required supplier documentation.
- Conducts Supplier PPAP (Production Part Approval) and schedules supplier audits at the supplier site on a regular basis, and writes audit reports.
- Implement and manage incoming, in-process, and outgoing inspections; manage the calibration of testing equipment, and measuring devices.
- Responsible for preparing quality assurance documents, training documents, workflows, instructions, engineering changes, and SOPs.
- Develops and implements appropriate quality training programs to ensure that quality programs and processes are carried out by staff throughout the company.
- Lead the activities to maintain all the documents in document control and change management in an organized way, and ensure that documentation follows cGMP, GCP, and GDP regulatory compliance.
- Oversee activities for CAPA implementation, investigations, and root cause analysis for non-conformances related to product, performance, process, or packaging and labeling.
- Successfully implemented product GUDID and UDI codes, and ensured all labeling and packaging activities were within compliance.
- Analyze, evaluate, and present information concerning factors such as business situations, production capabilities, manufacturing problems, data trends, and the design and development of new products for consideration by other members of the team.
- Leading all laboratory compliance and sterilization validation activities, ensuring that all microbiological testing and processes adhere to regulatory standards, internal quality requirements, and microbiology audits performed at on-site and contract sterilizer manufacturing sites.
- Responsible for writing post-market surveillance reports, clinical trial protocols and reports, and performing clinical studies/usability studies at different locations and countries based on country regulations.
- As a management representative, I am responsible for leading management review meetings and reporting data related to operations, quality, manufacturing, production, and sales to higher management, as well as internal quality assessment plots, and discussing further developments, changes, and related actions.
Research and Development Engineer -Quality Operations
Becton & Dickinson (BD)
New Jersey
06.2021 - 06.2022
- Quality Assurance support for the design and development of medical device products (Libertas Wearable Injectors), facilitating the application of design/change controls, risk management, quality plan, and implementation of design and development plans.
- Supporting multiple R&D projects, balancing priorities to meet project target deadlines, and management expectations.
- Review and sign off on all the documents related to validation, testing, and non-conformances.
- Work closely with the R&D and Manufacturing teams to address nonconformances, CAPA, and provide feedback on corrective actions.
- Leads the effort in developing and refining processes to reach product quality, efficiency, and process repeatability.
- Key focus on pragmatic risk assessments based on ISO 14971.
- Provided quality engineering support for planning, executing, and associated continuous improvement activities.
- Worked closely with suppliers to demonstrate and maintain stable, capable processes, and to maintain better quality improvement programs, and auditing systems with our suppliers.
- Conducted periodic quality audits at suppliers to verify that process capability requirements are maintained, as per ISO 13485.
- Resolved quality issues back to the supplier; this includes customer complaints and non-conformances.
- Developed and implemented statistically valid sampling plans, designed experiments, conducted capability studies, performed SPC, and carried out trend analysis.
- Collaborate with other departments and facilities within the company on quality-related issues, effective corrective actions, and valid statistical techniques.
Life Cycle/Supplier Lead Quality Engineer
Ethicon, Johnson & Johnson
Ohio
06.2019 - 06.2021
- Worked as a Life Cycle Quality Engineer for the Product Life Cycle Team, assisting the internal Product Development team with Device Verification and Validation, Prototype Builds, facilitating Risk Analysis, Process Reliability, Design Control, change orders, and integrating quality controls into documentation.
- Worked with a new, dedicated Product Focus Team (PFT) for assigned products, working solely on production line transfers.
- Helped the project lead to plan, manage, prioritize, and execute the necessary activities to ensure successful line transfers.
- Worked with suppliers, the life cycle team, and the regulatory compliance team to establish precise requirements for product standards (surgical staplers).
- Provided supplier quality engineer support throughout the product life cycle, and reviewed the product data coming from first article and incoming inspections, recommending advanced strategies to improve the product quality.
- Worked on Continuous Improvement Projects (CIP), responsible for controlling and optimizing process inputs that lead to cost improvement with better quality.
- Responsible for providing SME inputs, quality checks, and reviewing quality system documentation, and component requirement review documents.
- Developed test methods and participated in the assessment of returned products, incoming products, in-process products, and final test/inspection.
- Worked on equipment software validation and automation control validation before releasing the equipment into the production floor.
- Interface directly with the manufacturing team to resolve process and product design issues.
- Responsible for authoring and distributing process and product development documents and engineering study reports through PLM software tools.
- Organize, control manufacturing documentation to ensure the product is built from the most current documentation.
- Responsible for qualification testing, design reviews, gathering and analyzing data for capability studies using statistical tools like Minitab to ensure new products, processes, and equipment are capable of meeting customer requirements.
- Contributed to the development and implementation of product test plans and computer system validation standards, including templates for the verification and validation of products and processes.
- Developed and performed test methods for product testing, writing, and updating test procedures as required to ensure the quality system is compliant with regulations, including FDA, ISO 13485, and Medical Device Regulation (MDR).
- Worked closely with QA, engineering, and operational areas to evaluate actual and potential failures of the product, and update risk management files, DFMEA and PFMEA.
- Responsible for identifying production issues, performing root cause analysis under the guidance of the PM Development Engineers, and supporting corrective/preventive actions (CAPA).
Quality Engineer
Vistakon, Johnson & Johnson
Jacksonville, FL
07.2017 - 06.2019
- Involved in new product line validation for 5th generation technology equipment (5GT).
- I have been in the Quality Assurance Team, doing all quality operations and testing operations.
- Worked on facilities, utilities, and equipment validation for a new production line for J&J Vistakon product (eye lenses).
- Held responsible for writing, planning, and executing validation protocols and reports.
- Worked on developing all the facilities/utilities commissioning blue/green tag documents for various systems, like DI water system, compressed air, resin feed, HVAC, BMS, electrical, HHW, clean steam, and fire and security systems.
- Part of evaluating and testing new or modified solutions through commissioning and qualification for validation (IQ/OQ/PQ).
- Responsible for writing URS, FDS, and DDS documents, as well as computer system validation reports for PLC and HMI systems.
- Worked on the Retrospective Performance Qualification for Injection Molding Machines (IMM) in the lens manufacturing process.
- Used plastic data from production lots to validate the performance of the injection molding process for FC/BC, with the statistical claims and tolerance interval calculation using Minitab, Gauge R&R, SPC methods, and design of experiments (DOE).
- Assured product conformance through historical data analysis, performed process capability analysis (Cp and Cpk) using design of experiments (DOE).
- An investigation on the data not meeting the tolerance interval requirements was conducted to perform root cause analysis and document the findings.
- The respective corrective/preventive action (CAPA) was taken to minimize the risk of failure and the minimal impact on the IMM process.
Project Design Engineer
Toyota Kirloskar motor Pvt. Ltd.
India
06.2014 - 07.2015
- Intimately involved in producing product prototypes using drafting tools, computer assisted design (CAD) and managing projects
- Supported product launches, Engineering changes and/or improvement changes at customer location and ensures Quality systems are updated to compliance
- Assigned responsibilities of identifying production issues and performing root cause analysis under the guidance of the senior validation engineer
- Investigated defective parts on the assembly line or in the warehouse to confirm root cause of the problem
- Analyzed scrap and nonconformance data to drive yield improvements, monitor and improve the quality performance
- Assisted engineers to conduct successful failure mode analysis and root cause determination
- Maximize analysis of system, design, process, service, and safety FMEA's
- Developed and maintained product verification and testing documentation that was consistent with Quality System Regulations and compliant with both ISO standards
- Created complex, detail-level CAD models and drawings from sketches, mathematical equations or imported data files
- Evaluated designs, tooling and manufacturing processes to drive projects
- Able to interpret the results in testing for acceptance and comparison
- Worked on design data and ERP once the final design has been established
- Determined design proposals with factors from previous models
- Designed modifications to existing process piping systems
- Surveyed client's facility prior to starts of design for modifications to existing equipment
- Optimized workflow to produce quality results within budget and time constraints
- Conducted site assessments with the project engineer
- Researched the impact of emissions on the environment and helped in designing eco-friendly emission systems
- Established a design model in such a way where Efficiency, Quality and Safety were improved
Education
Master's - Mechanical Engineering
Northern Illinois University
12.2016
Bachelor's - mechanical engineering
05.2014
Skills
- Quality Management Systems
- Subject Matter Expert (SME)
- Process Development
- Quality System Regulation (QSR)
- Mechanical Testing
- Product Development
- Device/Equipment Verification and Validation IQ/OQ/PQ
- Software, Calibration, Test Equipment, Validation
- Continuous Improvement
- FMEA
- Design of Experiments (DOE)
- DMAIC
- Statistical Process Control
- Six Sigma
- Lean Methodologies
- Non conformance , RCA & CAPA Implementation
- Management review meetings
- Gauge R&R
- Customer relations
- Change management
- Data analysis
- Risk management
- Training and development
- Strategic planning
Internship
Design Engineer (INTERN/Co-Op), Vishakhapatnam Steel Plant, India, 05/01/13, 12/01/13
Certification
- Six sigma certification
- Statistical Process Control (SPC)
- Measurement system Analysis (MSA)
- Statistics 1, 2 & 3 Courses with Minitab Application
Accomplishments
- Member of the Automotive Engineers, for 5 years (2012-2017).
- Honored with the scholarship of $36,000 for graduation by Northern Illinois University.
- Received Best Performance Award by Steel Plant for developing and implementation of new molding Process.
Timeline
Quality Lead/Regulatory (PRRC) / Management Representative
Innovative Health Sciences
05.2022 - Current
Research and Development Engineer -Quality Operations
Becton & Dickinson (BD)
06.2021 - 06.2022
Life Cycle/Supplier Lead Quality Engineer
Ethicon, Johnson & Johnson
06.2019 - 06.2021
Quality Engineer
Vistakon, Johnson & Johnson
07.2017 - 06.2019
Project Design Engineer
Toyota Kirloskar motor Pvt. Ltd.
06.2014 - 07.2015
- Six sigma certification
- Statistical Process Control (SPC)
- Measurement system Analysis (MSA)
- Statistics 1, 2 & 3 Courses with Minitab Application
Master's - Mechanical Engineering
Northern Illinois University
Bachelor's - mechanical engineering
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