Senior Quality Engineer (287144) Bachelors, Green Belt, Class A Injection Mold Builder, Tool Maker / Machining, Molding, Foundry, Casting, Extrusion, EDM, CBM, Welding / Dallas Texas Area

An accomplished Senior Quality Engineer and ToolMaker with over 20 years of experience in the manufacturing industry, He has a Bachelors degree, is a Six Sigma Green Belt and a Certified Class A Injection Mold Builder. He has a strong track record of developing and implementing comprehensive quality systems and ensuring compliance with specifications/regulations. His background in Quality and as a ToolMaker provides him with a unique skillset when it comes to working with plastic molded and machined components. He is familiar with Die Casting Foundry, Machining, Injection Molding, Blow Molding, EDM, CBN, and Extrusion operations. He is recognized for building and leading quality teams while driving continuous improvement initiatives that have achieved up to 77% cost reductions and 50% yield rate improvement in critical manufacturing processes.

His contract position ended and he is now looking for a new opportunity apply his BIG BOX of skills for some lucky manufacturing company. His expertise in audits, process optimization, and supplier development makes him an ideal candidate for roles requiring leadership in quality management and supplier compliance. He lives in NE Dallas. His notable experience includes:

• Led gap assessments and developed strategic solutions for ISO 13485 and FDA 21 CFR compliance.
• Partnered with SMEs to resolve regulatory action items and CAPAs.
• Built and implemented a comprehensive Supplier Quality Department from the ground up.
• Managed supplier audits ensuring 100% regulatory compliance.
• Spearheaded supplier improvement initiatives, including CAPA management and inspection enhancements.
• Implemented Ship-to-Stock program leading to a 20% cost reduction.
• Played a key role in launching the company’s largest product line on schedule.
• Directed over 100 supplier audits ensuring compliance with ISO, FDA, and cGMP standards.
• Achieved 45% cost reduction and 98% yield improvement in injection molding processes.
• Led the transfer of 100+ tools to new suppliers while managing cost, timeline, and safety stock.
• Implemented supplier quality programs that improved compliance and reduced defect rates.
• Developed supplier validation protocols aligned with ISO and FDA standards.
• Optimized manufacturing processes, increasing efficiency and reducing costs by over 75%.
• Led product launches and process improvements, collaborating with R&D, engineering, and regulatory teams.
• Six Sigma Green Belt
• Lean Certified
• Class A Injection Mold Builder Certification

• QMS – Quality Management System
• cGMP
• Managing Quality Teams
• Leading Kaizen Events
• Working With Lean Teams
• Leading Six Sigma Teams
• Change Management
• Performing Kanbans
• Calibrating Equipment
• Using CMM Equipment
• Programming CMM Equipment
• 3D Scanner
• Optical Comparator
• Hardness Testing
• Environmental Chamber
• Metallurgy
• Hardness Testing
• Technical Writing
• Gage R&R
• GD&T
• ISO Auditing
• Troubleshooting Root Cause
• Implementing Corrective Actions
• Implementing Continuous improvement
• Reducing Scrap
• Optimizing Manufacturing Processes
• De-bottlenecking Processes
• PPM Reduction
• Tooling Specifications
• Injection Molding/Tool Maker
• Part Design
• Process Capability Studies
• Material Selection
• Configuration Management
• Ship-to-Stock Program Implementation
• Reducing Manufacturing Cycle Time
• Vendor Offsite Supplier Quality
• Supplier Validation / Qualification
• Shop Floor Process Quality
• Quality Training Experience
• Production Quality experience
• Directing Quality Techs
• Tracking Concessions / Deviations
• New Production Line Startup
• Recommending Specification Revisions
• Creating SOP Training
• First Article Inspection FAI
• Quality Engineering
• Component Design Review
• Statistical Investigations
• Investigating Customer Complaints
• 5S / 6S
• 8D
• Ishikawa Diagrams
• Establishing Cpk For Process
• New Process Development
• Designing Process Improvement Trials
• Process Analysis
• Generating Process Control Charts
• Using Product Reject / Defect Investigations
• Working with R&D
• Delivering Cost Reductions
• Tracking Defects Per Unit
• Sorting Suspect Parts
• NADCAP
• PPAP
• APQP
• Toyota Production Systems
• SQL Database
• Minitab Software
• ERP Software
• SQC/SPC Package Software
• ISO Standards
• ASTM Standards
• ISO 9000, ISO900, ISO14001
• IATF16949/TS16949
• MIL-SPEC
• cGMP Regulations
• FDA Compliance
• cGMP
• Hazard Analysis Critical Control Points (HACCP)
• 21 CFR Part 820
• ISO13485

Education & Certifications
• Bachelor of Business Administration (BBA), American Intercontinental University (Cum Laude)
• ISO Lead Auditor Certification
• Six Sigma Certified
• Geometric Dimensioning & Tolerancing (GD&T) Expertise