Quality Engineer Design

Meghana Rao

Email: *****.******@*****.***

Phone: 937-***-****

CORE COMPETENCIES:

Gap Analysis, Continuous Improvement, Product design and development, Product Validation, Six sigma, Root cause analysis, FMEA, CAPA, Statistical analysis (Minitab), Process Audits, Quality assurance, Design History File (DHF), 21 CFR Parts 210,211,820, Process Validation conducting IQ/OQ and PQ, TMV, ETP, Verification and Validation Documents, FAI, Process Capability, Automation, Understanding of ISO 13485, 14971, Detailed Work Instructions, Design Validation Testing, Traceability Matrix, Microsoft Visio, CATIA, ANSYS, AutoCAD, ASTM A753, ISO 60601

Professional Experience:

Johnson & Johnson, Irwindale, CA

Project Lead Feb 2020 – Present

Analyze concepts received from suppliers and make recommendations, create reports and present it to Project team / customer stakeholders

Assisting in creating and managing the business case for each individual project within the program – feasibility of concepts, engineering analysis, cutting costs etc.

Monitoring of the spend data to generate ideas for new CIPs (Capital Improvement Program).

Make monthly and quarterly reports to the management core group on project status and financial benefit generated

Responsible for implementing and maintaining supplier qualification/ disqualification, supplier monitoring, product design changes.

Developed and Maintain monthly metrics sheet for various projects in Ideation and F1 phase which includes the status of the projects along with the budget, charter date, cost savings, Implementation timeline among others.

Conduct regular management reviews, monitor and manage dependencies, monitor and mitigate risks, escalate roadblocks for project teams

Analyzed and evaluated various concepts (Extrusion, Molding, Machining, stamping etc) for efficient process outcomes with effective cost savings.

Assess the feasibility of the proposed concepts namely design change, material change and process change., through rigorous testing to provide proof of concept.

Provide program updates to the cross functional leadership team to ensure execution discipline across the region

Review the drawings submitted by the suppliers in Solidworks and provide feedback with the help of SME.

Develop and maintain relationships with global and regional teams dedicated to the assigned project portfolio

Manage the implementation of external partner's activities associated with program implementation to ensure that all solutions adhere to J&J standards.

Leverage synergies to promote best practice sharing and develop project management expertise among team members.

Collaborate with various suppliers in quality assurance processes and procedures to facilitate continuous improvement of supplier and product performance.

Participated in supporting quality disciplines, decisions, and practices.

Analyze the designs in AutoCAD/CATIA to determine the feasibility of the design.

Assist teams to perform in depth IQ/OQ/PQ protocols for mechanical components in order to ensure complete validation in adherence to cGMP and 21 CFR 11 requirements

Worked on Design change project for PCB for one of the therapeutic catheters as part of NPD. The project is still in initial stage.

Manage offshore team based on the work provided by the management, schedule meetings between teams for proper communication.

Assign work to offshore team in analyzing various concepts provided by the suppliers.

Add new ideas to the pipeline every month with a target of 6.6 million USD.

Validate Supplier’s products conform to Applied material Specifications through FAI process. This includes reading drawing and specification and comparing it with supplier’s data to ensure compliance.

Drive projects for continuous cost improvement opportunities by exploring all possible options, for eg single cavity molding/ multicavity molding, machining/molding, manual/automated etc

Design a new test method to test magnetic permeability for various types of materials.

Assess the components used in Legacy products to come up with new innovative ideas with cost saving opportunities.

Come up with new process change, design change, material change or supplier change recommendations

Assess business continuity risk and work with various suppliers and in house for a solution.

Conduct and create various testing procedures for different components related to both electrical and mechanical (material change, design change, process change etc) to confirm the feasibility of the project.

Communicate with suppliers to evaluate the concepts received and escalate the most feasible projects with high cost saving opportunities to J&J management.

Conduct Verification and Validation testing to check the products adherence to product specifications, industry standards, best practices, quality & regulatory procedures and requirements to accurately teat and release quality products.

Ability to work in tight deadlines.

Identify opportunities to revise and improve product design or product performance and implementing these improvements.

Abbott Labs, Los Angeles, CA

Quality Engineer July 2018 – Oct 2019

Project Description:

The high-level scope of the project is to integrate the Quality Management System (QMS) of Legacy St. Jude Medical with Abbott Laboratories (CRM Division) QMS and other international regulations and standards (FDA, ISO &EU MDR). The scope also includes continuous improvement of the existing medical devices and new product development in Abbott through six sigma methodologies.

Edit and prepare new/revised Design History files and Design Control documents that are submitted for the design control processes.

Create and update device configuration documents, Design transfer to Manufacturing (DTM) documents, change summary documents as required.

Participated in FMEA and Operational Quality Risk Assessment processes to help reduce process deviations.

Define and execute process qualification documents (PFMEA, TMV, IQ, OQ, PQ)

Establish Engineering Change Orders (ECO) with their respective documents like Change Impact form (CIF), training plan and prepare for change authorization and documentation as well as review an analyze change orders and coordinate changes with engineering, quality and manufacturing.

Represented Quality and supported product design and development teams assisting in product qualification, validations, and risk management during Internal Audit.

Reviewed and maintained Design History Files.

Established Product Quality and Inspection Plans to manage in-process & out-going product evaluation points, levels and criteria.

Provide electronic storage for record retention to create images of documents and records. Indexes and organize records based on standardized cross-filing system which can be retrieved in a timely manner.

Developing new DWIs (Detailed work Instructions) and updating existing DWIs for equipment and manufacturing processes.

Worked with other test engineers and provided technical guidance as necessary like extracting stored information on the pacemaker, reviewing the data for errors etc during verification of firmware upgrade of the pacemaker.

Ensure DHF content is complete as well as check integrity & standard compliance while collaboratively communicating and resolving gaps.

Performed wireless coexistence testing on new Implantable wireless device in different environments.

Responsible for setting up environment similar to FDA-C63 lab with several wireless networks, BLE accessories, mobile networks, RFID chips etc

Responsible for collecting data and development of new requirements form for Design Validation Testing.

Performed mobile application testing to monitor ICD mimicking the device inserted in human tissue using other means.

Responsible for upgrading ICDs to new firmware versions to test as part of New Product Development (NPD).

Provides analysis of internal Quality issues and provides recommendations for improvements.

Participated in supporting quality disciplines, decisions, and practices (e.g., represent the Quality function as a Core Team Member)

Worked towards completion and maintenance of risk management documents

Work with design engineering in the completion of product verification and validation

Partnered with NPD and Manufacturing during the entire development and transfer process

Supporting the Program Management team with revamped NPD process.

Worked on creating a DWI for Design Traceability Matrix and created a traceability matrix for Implantable Cardiac Device (ICD).

Performed gap analysis on FDA standards to check the compliance to those standards and gave the results to respective teams.

Machine Solutions, Flagstaff, AZ

Quality Engineer May 2016 –June 2018

Responsible for maintaining Quality Management System including assuring effective management reviews, complaint handling, CAPA system, change control, calibrations maintenance, validation, internal auditing, training, R&D transfers, and manufacturing area support.

Perform CAPA investigations including root cause analysis using Fish Bone analysis, Pareto analysis and other Edwards recommended tools, vendor materials quality data analysis, review DHRs, etc.

Closely collaborate with cross functional teams to drive robust design validation and product line implementations

Provide support and insight into qualification and validation activities and work effectively with engineering and operations teams in completing these tasks.

Prepared test protocols and final reports for the verification and validation testing of new products.

Worked on Design improvement & optimization and study of feasibility of manufacturing.

Participated in design review meetings.

Remediated past Design History Files per FDA standards and compliance.

Drive continuous improvement of legacy products to increase manufacturability and performance

Develop Technical Studies, Risk Analysis, Process Mapping, DOE’s, Gap Analysis, Statistical Rationales, Discrepancy Reports, among other documentation.

Responsible for Customer Complaint Investigations, CAPA projects, Cost Reduction and Continuous Improvement projects, Quality Systems Excellence among other projects.

Supported product design and development teams assisting in product qualification, validations, and risk management.

Reviewed and maintained Design History Files.

Performed duties as required to support Supplier Quality Management program including supplier qualifications, on site audits, audit schedule, quality agreements, performance monitoring, corrective actions and pursue continuous process and yield improvements.

Partnered with NPD and Manufacturing during the entire development and transfer process

Vizag Steel Plant, Andhra Pradesh, IN

Internship Nov 2013 –Apr 2014

Undergone Industrial training on Quality Assurance and technology development on production of steel.

Helped Quality control department in writing TMVs.

Helped the Quality Control department in testing different kind of products manufactured at the plant by doing destructive testing using hydraulic press.

Received training in maximizing extrusion output and yield performance.

Observed in-depth working of boilers in the plant.

Projects:

Deep Drawing 6 months

Deep drawing is a sheet metal forming process in which a sheet metal blank is radially drawn into a forming die by the mechanical action of a punch.

Tested various materials with different parameters until we got the most optimum results.

International Series of Karting Championship 6 months

Team Leader and Design Head

Designed a Go Kart, a small four wheeled vehicle manufactured according to the tight guidelines set by the competition.

Actively involved in the decision-making process of selecting strong materials and engine for the manufacturing of the kart while not compromising with the safety.

Assembled the go kart in house with the help of a team of 16 people complete with transmission, brakes and steering.

Designed and performed FMEA on the chassis for the best possible outcome while considering the other team’s (Steering, brakes, transmission) requirements, safety and cost with the help of CATIA and ANSYS.

Won Best Design in the competition.

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