Continuous Improvement Manufacturing Quality

Sai Sushma M

Email:********************@*****.*** Ph: +1-940-***-**** Dallas, TX

SUMMARY

Manufacturing Quality Engineering professional with 6+ years of experience in product quality, process improvements, quality system compliance with ISO 13485, ISO 9001, and FDA 21 CFR part 820 knowledge.

Experience working on Class II and Class III medical devices.

Experience in researching new industry technologies, to deliver improved product solutions and reducing costs

Experienced in driving cost down projects, value engineering and new product introductions.

Strives for continuous improvement by establishing processes for effective procurement process

Skilled in validating CAPAs through data analysis and testing, ensuring root cause resolution and compliance with quality standards.

Experience in driving cross-functional projects on quality initiatives, CAPAs and change control activities.

Experience in leading weekly MRB meetings to maintain timely dispositions, trend scrap and rework efforts.

Experience in driving RCA activities to correct/prevent internal OOS and deviations.

Strong understanding of engineering drawings, principles and resourceful in technical documents preparations.

Knowledge of incoming inspection, FAI requirements and pair findings with in-process nonconformances to draw product failure maps.

Skilled in coordinating efforts with engineering, production, and other cross functional teams to efficiently resolve NCs.

Strong understanding of engineering drawings & principles & resourceful in preparation of technical documents Engineering Release & Engineering Change Issues

SKILLS

1-

Lean Manufacturing, Six Sigma (DMAIC) practices, Design for Six Sigma (DFSS) methodologies, Root Cause Analysis/Investigation, IQ/OQ/PQ, Process Validation and Verification, PFMEA, Risk Management, Risk Assessment, NC’s, CAPA, NCR, GAP Analysis, PPAP, APQP, FAI, MS Office, Cross Team Collaboration and FDA & ISO regulations (21CFR Part 820, ISO 9001, ISO 13485, and ISO 14971)

WORK HISTORY

Quality Engineer II March 2024- Present

Zebra Technologies, Fort Worth, TX

Managed quality control procedures and systems to ensure the evaluation of organizational processes and products met customer specifications and reliability standards.

Conducted regular assessments to determine the effectiveness of current methods and techniques, making modifications as necessary for continuous improvement.

Created and documented standard operating procedures (SOPs) to streamline quality processes and enhance product reliability.

Actively communicated customer concerns and issues, facilitating timely resolutions, implementing corrective actions and preventive measures to mitigate risks through collaboration with cross-functional team members.

Applied root cause analysis, FMEA (Failure Mode and Effects Analysis), and 8D methodologies to systematically identify and resolve quality issues.

Utilized Statistical Process Control (SPC) and problem-solving tools to analyze data and identify areas for improvement.

Implemented Design of Experiment (DOE) formats to optimize processes and product quality.

Ensured compliance with ISO 9002 and TS16949 requirements, maintaining a robust Quality Management System.

Conducted internal and external audits to ensure compliance and identify areas for improvement within the QMS.

Managed the CAPA process from identification to resolution, ensuring timely and effective corrective measures were taken to prevent recurrence of issues.

Senior Manufacturing Quality Engineer

Zimmer Biomet -Warsaw, IN, US. Sep 2021– Jan 2024

Served as Senior Quality representative during new product launches/transfers and modifications of sourced product into production including process validation (IQ, OQ, PQ) activities. Conducted supplier performance evaluation and monitoring.

Conducted gap analysis of documented procedures vs on-the-floor manufacturing practices to identify process deviations

Drafted, reviewed, and implemented validation protocols, final validation reports, Quality System procedures, performance qualifications, and Engineering Change Orders (ECO).

Conducted device history record (DHR) reviews and signed off batch releases.

Initiates Events ( Deviations, CAPAs, Change Controls, Complaints) in the eQMS and routes appropriately to closure.

Conducted evaluations on process inputs and process outputs using statistical methods (such as DOE) and oversaw test execution.

Conducted inspections and quality checks to ensure all products met stringent cosmetic standards.

Led Corrective and Preventive Actions (CAPA) to address injection molding defects, employing root cause analysis and collaboration with cross-functional teams to implement effective solutions and prevent recurrence

Compiled and evaluated data to determine appropriate limits and variables for process and part specifications, ensuring product consistency and reliability.

Developed and maintained a comprehensive labeling checklist to verify accuracy and compliance of all product labels

Oversaw the development of detailed testing protocols and validation procedures to guarantee product functionality.

Executing the operational qualifications and performance qualifications for Tyvek and pouch sealing validations with challenging and nominal conditions as per the Sealer process.

Qualifying Equipment such as Belco and Multivac sealers to support packaging validations.

Developed and maintained key performance indicators (KPIs) to track the effectiveness of CAPA processes and identify areas for improvement.

Managed the quality assurance for electro-mechanical equipment, executing FMEA and enforcing rigorous testing and validation protocols.

Demonstrated a record of proactively identifying NCs in manufacturing processes and product quality through inspections, audits, and quality control methods.

Conducted in-depth root cause analysis using 5 Whys, Fishbone Diagram, and Failure Mode Effects Analysis (FMEA) to understand the origin of NCs.

Utilized data analysis tools and methodologies to assess trends and patterns in CAPA data, facilitating proactive problem-solving and process improvement.

Ensured compliance with the supplier performance management system. Managed CAPAs for QMS non-conformances identified, measured suppliers’ performance by conducting trend analysis, identifying system issues, summarized findings and prepared reports for key quality and product metrics.

Initiated SCARs for non-conformances, setting priorities for corrective action efforts, and worked with the team on component related failure investigations.

Developed Installation, Operational, and Performance Qualification protocols for commissioning and validation.

Assisted Site Quality teams during internal and external audits.

Develop Process maps, Pareto charts, PFMEAs, and Control Plans for hardware in pre-production development phase.

Maintained site-level quality documentation to meet necessary Quality Management (QMS) system requirements.

Ensured all incoming material is properly identified with an EM part number (if applicable), supplier’s part number (if applicable), manufacturer’s part number, EM Research’s Receiving Inspection Log (RIL) number, and complete the appropriate inspection log form.

Manufacturing Quality Engineer

Stryker, Gurugram, India Mar 2017 - April 2021

Managed quality performance and scorecards.

Participated in Material Review Board (MRB) for disposition of nonconforming products.

Design verification using Pro Engineer by applying GD&T and checking it on finished parts.

Conducted weekly PPAP reviews for quality.

Conducted root cause analysis for resolving supplier-related quality issues identified internally and those identified through customer complaints/returns using CAPA.

Development and implementation of Quality Documents and initiatives to sustain and improving Quality Systems.

Developed and carried out performance tests to characterize and document safety parameters.

Executed Test Method Validation of Test Fixtures, Test Assemblies and Gauges.

Executed approved process validation (PV) protocols using validated test methods.

Developed IQ, OQ, PQ protocols for Equipment and Process validation studies.

Led execution of Gage R&R study to determine part variations and also manually inspected the dimensions of the parts using optical comparators, Vernier calipers and micrometer.

Provide hands-on support and troubleshooting of manufacturing processes, tooling and equipment.

Analyze and document the management of material, process changes, qualification activities, compliance activities, and CAPA's.

Generate all related manufacturing WI documentation in compliance with QMS procedures.

Support manufacturing facility transfer and product transfer activities to offshore facilities.

EDUCATION:

Masters in Engineering Management (Industrial Engineering), University of North Texas, USA

Bachelors in Engineering Technology, JNTU, Kakinada, INDIA

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