Quality Engineer Lean Manager

Natalia Ziserson

San Diego, CA ***** Phone :858-***-****

*******@*****.***

Result oriented, team player and enthusiastic engineer with strong quality and analytical skills and 17 years of manufacturing/ quality engineering experience ( Lean, QE and MFG Eng) .

EXPERIENCE

Illumina Corp, San Diego, CA 2020– Precent

Staff MFG/OPS Quality Engineer (Medical Devices)

Responsible for Sustaining Quality Support of Fill, Formulatioin and Pack Reagents Area

•Provided quality leadership to new product development teams in the areas of design control, design verification and validation, design transfer, process validation, risk management, and specification development.

•Provided ongoing quality engineering support throughout the product life cycle.

•Provided support to development, engineering and manufacturing functions for validation planning and transfer activities.

•Assisted teams in determining validation needs and requirements.

•Ensured adequacy of complaint, non-conformances and CAPA records, investigations, and corrective actions.

•Aided in the assessment and qualification of new supplier materials such as component specifications and inspection standards.

•Reviewed verification and validation reports and identify gaps for GMP compliance.

•Developed and execute strategies to close gaps in an efficient, technical, and compliant manner

•Trended, analyzed, and reported on quality data in order to improve product and process.

•Developed recommendations based on data analysis.

Philips Health Care, Carlsbad, CA 2018-2020

Lean Manager (Medical Devices)

Responsible for Continuous Process Improvement Cross Site

•Teaching Lean/6 sigma tools including 6S, problem solving, Daily Management and VSM.

•Leading problem solving in the areas of yield improvement, capacity planning & line balancing.

•Hands on manufacturing and assembly experience in a production floor.

•Planning and leading Project Reviews.

•Have an ability to drive the team and executive management to manage variables in adverse conditions

•Managed the Global Lean project of MFG process improvement, cost saving and process efficiency.

Cliniqa Corporation, San Marcos, CA 2015-2018

Senior Quality, MFG and Lean Engineer (Medical Devices)

Responsible for Manufacturing process developement and Quality Support

•Analyzed, developed and implemented improvements into manufacturing process using Kaizen methodology, Lean, RCCM and VSM.

•Functioned as a team leader in a project to ensure in time deliveries and to coordinate activities among cross functional groups.

•Performed validations of medical equipment: installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ), Standard Operating Procedures (SOP), FMEA.

•Performed validation of systems, utilities, and processes based on standards of Food and Drug Administration (FDA), and ISO.

•Actively participated in internal, customer, and third-party audits.

•Led company Transformation Plan process.

Zodiac Pool Systems, Vista, CA 2014-2015

Manufacturing Team Lead

Responsible for relocation of Manufacturing Area from CA to Mexico( project cost $35M)

•Developed and improved manufacturing methods, processes and documentation: BOM, WI, Process Maps, ECO, FAI, PFMEA, CO

•Performed equipment validation (IOPQ) and troubleshooting.

•Controlled continuous improvement of manufacturing and quality processes (LEAN, Kaizen, RCCM) to reduce/improve cycle time, lead time and material flow (CCF/MMF)

•Analyzed assembly/test failures, identified root causes and performed corrective actions: 5Why’s, fishbone diagrams.

EDUCATION

Master's degree, MBA (Global Business Management)

Ben-Gurion University, Beer Sheva, Israel

Bachelor degree, Industrial/ Manufacturing Engineering

SCE University, Beer Sheva, Israel

Certificate, Lean Enterprise

SDSU, San Diego, CA

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