Results-oriented Quality Supervisor specializing in quality management and regulatory compliance. Recognized for effectively executing process enhancements and performing thorough audits, ensuring adherence to ISO 9001 standards to foster organizational excellence.
Overview
12
12
years of professional experience
4
4
Certification
Work History
Quality Supervisor/ISO 9001 Coordinator
Kennedy Valve
Elmira, NY
05.2019 - Current
Act as the Quality Management Representative, ensuring compliance with ISO 9001 standards through effective implementation and maintenance of the quality management system (QMS).
Conducted audits to verify adherence to established quality procedures.
Delivered hands-on improvements using process mapping, standard work, and 5S workplace organization.
Developed a cohesive quality team within production to enhance process checks and quality assurance.
Investigated and resolved customer complaints related to product quality.
Identified training needs for quality-related skills and delivered targeted training sessions.
Maintained documentation controls to support quality management processes.
Executed root cause analysis using Corrective/Preventative Actions to resolve issues.
Machine Operator/ Inspector
DePuy Synthes (Companies of Johnson & Johnson)
Horseheads, NY
12.2012 - 05.2019
Ensure all Critical to Quality (CTQ) customer requirements are met in the packaging area for all medical devices such as titanium, stainless steel, and PEEK orthopedic implants and instruments.
Support ISO, J&J internal audits, and FDA Regulatory audits.
Complete packaging operations per documentation and specific procedures; trained in GxP practices.
Execute finishing operations such as anodize, electro polish, passive, final clean and rinse.
Work in accordance with all requirements for manufacturing medical devices according to J&J and FDA regulations.
Performed production control transactions for processing product through the production process for shipping.
Perform final inspection which required the use of gages and inspection sheets.
Provided feedback to production supervisors and cell operators.
Mentored Quality Engineering Lead for additional job experiences using ETQ for non-conformance recording.
Finishing Operator
Corning Inc (Diesel Facility)
Corning, NY
01.2010 - 01.2012
Completed all finishing duties to heavy duty diesel catalytic converter substrates. Including but not limited to repair, testing, packaging, and inspection per required documentation.
Supported ISO 9001, ISO 14001 and Customer audits.
Quality Assurance Trained- Responsibilities included but not limited to inspecting parts per spec sheet and ensuring prompt and accurate customer shipments.
Used multiple gauges such as: laser gage, depth gage, light boxes, etc. for inspection of final product per specification sheets.
Set-up of machinery for job changes when new products were to be tested and released to the customer.
Entered data into QA database for Quality to review to ensure product met critical customer requirements.
Team Leader
The Beam Team
Alpharetta, GA
01.2005 - 01.2010
Subcontractors hired by leading realtors such as The Home Depot, Family Dollar, Grainger, Dollar Tree, Kiosk and Staples.
Required to assemble displays, gondola racking, merchandise, and ensure overall quality of store setups.
Team Leader of teams from 2 to 20 members providing direction daily.
Facilitate the opening of a business from empty building to fully operational i.e.: Family Dollar, Grainger, Kiosks.
Responsible for the supervision of staging incoming shipments including unloading of trucks, taking notes of what is missing, preparing checklists of missing parts and fixtures, construction of all racking, etc.
Perform surveys, record inventory of incoming shipments to ensure products properly loaded and delivered.
Education
Bachelor of Art - Business Information Systems, Operations Management
Ashford University
Clinton, IA
Master of Business Administration - Project Management
University of the Southwest
Hobbs, NM
Skills
Quality management
ISO 9001 compliance
Root cause analysis
Process improvement
Audit coordination
Regulatory compliance
Problem solving
Attention to detail
Customer complaint handling
Calibration management
Supplier quality management
Corrective actions
Microsoft office
Certification
Geometric Dimensioning and Tolerancing (GD&T)
Six Sigma Green Belt Johnson&Johnson- Execution of Packaging Materials Optimization
Certified Quality Technician (CQT) –American Society for Quality
DePuy Synthes Encore Awards for supporting cells production and cost savings implementations
Six Sigma Green Belt- American Society for Quality
Safety Champion of the Month for safety implementations.
R.G. Loewenguth Co., Inc. (Smartscope- optical measuring systems) Certified
QE Certification Program (Johnson & Johnson)
ISO 9001:2015 Lead Auditor Certified (Exemplar Global/American Society of Quality)
FARO CAM2 Measure Arm Certified
Mohawk Global Trade Advisors Import/Export Compliance Certified
Timeline
Quality Supervisor/ISO 9001 Coordinator
Kennedy Valve
05.2019 - Current
Machine Operator/ Inspector
DePuy Synthes (Companies of Johnson & Johnson)
12.2012 - 05.2019
Finishing Operator
Corning Inc (Diesel Facility)
01.2010 - 01.2012
Team Leader
The Beam Team
01.2005 - 01.2010
Bachelor of Art - Business Information Systems, Operations Management
Ashford University
Master of Business Administration - Project Management