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Vicki Ballon is listed as Medical Device Quality / Operations Engineering Professional based in Mission Viejo, California, United States. AeroLeads shows a work email signal at lensgen.com and a matched LinkedIn profile for Vicki Ballon.
Vicki Ballon previously worked as Manager of Quality Assurance at Lensgen, Inc. and Principal Quality Engineer at Lensgen, Inc.. Vicki Ballon holds Bachelor'S Degree, Mechanical Engineering (Biomechanical Concentration) from Cornell University.
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Committed engineering professional with over 15 years of medical device quality and manufacturing experience. Wide breadth of experience across quality engineering, manufacturing engineering, industrial engineering, production planning & scheduling and manufacturing management in class III ophthalmic, class III active implantable and class II perfusion products.Keywords: CQE, CQA, QSR, FDA, 21 CFR Part 11, 21 CFR Part 820, 21 CFR Part 806, ISO 13485, ISO 14971, Start-up, IDE, PMA, QMS, Site Transfer, Supplier Management, Inspection, NCMR, CAPA, Risk Management, FMEA, Process Validation, Test Method Validation, Root Cause Analysis, Cleanrooms, Environmental Monitoring, Sterilization, Design Control, Six Sigma, Lean Manufacturing, Line Balancing.
Listed skills include Quality System, Iso 13485, Medical Devices, Manufacturing, and 21 others.
A career timeline built from the work history available for this profile.
Irvine, CA, US
Managed documentation control, supplier management, environmental control, equipment control and quality acceptance activities. Executed and reviewed non-conforming material investigations. Authored or reviewed validation protocols and reports, risk management files and engineering change orders.
New York, US
Implemented monitoring for Quality Management System (QMS) processes, created product complaint trending charts, led cross-functional complaint review meetings and coordinated QMS gap assessments and updates for the transition from ISO 13485:2003 to ISO 13485:2016.
Performed product complaint trending, QMS gap assessments and implemented changes to QMS documents to ensure compliance with ISO 13485:2016.
Managed supplier quality management system, environmental monitoring program, product complaint investigations, calibration program and quality inspection activities. Provided direct supervision to a Quality Engineer, two Quality Inspectors and a Quality Technician. Executed and reviewed CAPA investigations, non-conforming material investigations.
Marlborough, MA, US
Lead manufacturing team to achieve committed build plan while maintaining compliance to the quality system and regulatory requirements. Held roles of increasing responsibility: production supervision, capacity planning, production planning supervision and production management. Provided direct supervision to product builders, industrial engineers and.
San Clemente, CA, US
Reviewed supplier audits, corrective actions and requests for change, non-conforming material reports, CAPAs and engineering change orders for Supplier Development, Manufacturing, Reliability and Design groups. Provided direct supervision to two quality technicians responsible for calibration and product acceptance activities.
Ann Arbor, Michigan, US
Reviewed non-conforming material reports and engineering change orders for Receiving Inspection, Manufacturing and Service groups. Led CAPA investigations and investigations on sub-system and system level non-conformances and complaints. Created inventory transfer plans, quality inspection procedures and risk management documentation, revised.
Ann Arbor, Michigan, US
Managed a variety of validation projects for equipment, software, and processes related to electro-mechanical and surgical products. Validated existing and new processes, revised manufacturing instructions, trained operators and supported production for the startup of a transfer product line from Mexico.
Evaluated and promoted child health issues in rural communities with the Nicaraguan Red Cross. Planned coursework and taught English to elementary school students.
Detroit, Michigan, US
Analyzed load data and circuit ratings to determine potential areas for applying distributed generation solutions. Compiled generation and interruptible data into a resource for substation operators to use in emergency situations.
Detroit, Michigan, US
Inspected pad-mount transformers and verified overhead transformer assignments.
Detroit, Michigan, US
Computer modeled circuits in Distribution Engineering Workstation (DEW) and trained new modelers. Maintained and enhanced departments web-page and database.
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Vicki Ballon is listed as Medical Device Quality / Operations Engineering Professional.
AeroLeads has found 1 work email signal at @lensgen.com for Vicki Ballon.
Vicki Ballon is based in Mission Viejo, California, United States.
Vicki Ballon has worked for Lensgen, Inc., 24 Seven Llc, Self-Employed, Revision Optics, Inc., and Boston Scientific (Formerly Cameron Health).
You can use AeroLeads to view verified contact signals for Vicki Ballon, including work email, phone, and LinkedIn data when available.
Vicki Ballon holds Bachelor'S Degree, Mechanical Engineering (Biomechanical Concentration) from Cornell University.
Vicki Ballon is listed with skills including Quality System, Iso 13485, Medical Devices, Manufacturing, Fda, Fmea, Validation, and Design Control.
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