Vicki Ballon work email
- Valid
- Valid
- Valid
Vicki Ballon personal email
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.
-
Manager Of Quality AssuranceLensgen, Inc. Jun 2023 - Jan 2024Irvine, Ca, UsManaged 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. -
Principal Quality EngineerLensgen, Inc. Aug 2019 - Jun 2023Irvine, Ca, Us
-
Quality Engineer24 Seven Llc Apr 2018 - Aug 2019New York, UsImplemented 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. -
Independent Quality Assurance/Engineering ConsultantSelf-Employed Apr 2018 - Aug 2019Performed product complaint trending, QMS gap assessments and implemented changes to QMS documents to ensure compliance with ISO 13485:2016.
-
Principal Quality EngineerRevision Optics, Inc. Apr 2017 - Mar 2018Managed 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, validation reports, returned product investigations, risk management files and engineering change orders.
-
Senior Quality EngineerRevision Optics, Inc. Aug 2014 - Mar 2017
-
Group Lead - ManufacturingBoston Scientific (Formerly Cameron Health) Oct 2011 - Aug 2014Marlborough, Ma, UsLead 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 production supervisors. -
Quality EngineerCameron Health (Aquired By Boston Scientific) Sep 2010 - Oct 2011San Clemente, Ca, UsReviewed 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. -
Quality EngineerTerumo Cardiovascular Systems Jun 2006 - Aug 2010Ann Arbor, Michigan, UsReviewed 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 specifications and provided training to support the cardiac monitoring product line site transfer. -
Manufacturing EngineerTerumo Cardiovascular Systems Mar 2005 - Jun 2006Ann Arbor, Michigan, UsManaged 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.
-
Student/VolunteerCentro De Idomas Neuva Segovia Jun 2004 - Aug 2004Evaluated and promoted child health issues in rural communities with the Nicaraguan Red Cross. Planned coursework and taught English to elementary school students.
-
Engineering InternDte Energy Jun 2003 - Aug 2003Detroit, Michigan, UsAnalyzed 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. -
Engineering InternDte Energy Jun 2002 - Aug 2002Detroit, Michigan, UsInspected pad-mount transformers and verified overhead transformer assignments.
-
Engineering InternDte Energy Jun 2001 - Aug 2001Detroit, Michigan, UsComputer modeled circuits in Distribution Engineering Workstation (DEW) and trained new modelers. Maintained and enhanced departments web-page and database.
Vicki Ballon Skills
Vicki Ballon Education Details
-
Cornell UniversityMechanical Engineering (Biomechanical Concentration)
Frequently Asked Questions about Vicki Ballon
What is Vicki Ballon's role at the current company?
Vicki Ballon's current role is Medical Device Quality / Operations Engineering Professional.
What is Vicki Ballon's email address?
Vicki Ballon's email address is vb****@****gen.com
What schools did Vicki Ballon attend?
Vicki Ballon attended Cornell University.
What skills is Vicki Ballon known for?
Vicki Ballon has skills like Quality System, Iso 13485, Medical Devices, Manufacturing, Fda, Fmea, Validation, Design Control, Root Cause Analysis, Testing, Cross Functional Team Leadership, Engineering.
Free Chrome Extension
Find emails, phones & company data instantly
Aero Online
Your AI prospecting assistant
Select data to include:
0 records × $0.02 per record
Download 750 million emails and 100 million phone numbers
Access emails and phone numbers of over 750 million business users. Instantly download verified profiles using 20+ filters, including location, job title, company, function, and industry.
Start your free trial