Quality Engineer/Manager (225617) Green Belt, CQA / Tier 1 & 2 / Injection/Blow Molding, Welding, Assembly / Renting, Will Relo
Quality Engineer with 20+ years of experience supporting machining, Tier 1, Tier 2, injection/blow molding, welding, and assembly operations. He is a Six Sigma Green Belt and is skilled in using a variety of industry software including SAP and JDE ERP Systems. He recently completed a contract role and is looking for a permanent role.. He has managed quality personnel and has been a single contributor. He is renting and is willing to relocate. He is looking for $90k and a bonus opportunity. His notable experience includes:
• CAPA team participation in corrective action identification, implementation, and verification of effectiveness
• Develop and implement QMS documentation
• Create tier 2 SOPs and work instructions
• Manage customer complaints (investigations, root cause analysis, corrective actions)
• Lead transition from commercial to medical device component manufacturing
• Develop and implement Quality Management System (ISO 13485: 2016)
• Develop and implement a certified Quality Management System (ISO 9001: 2015)
• Manage the Quality Assurance department (6 employees)
• Internal Auditor (ASQ – Certified Quality Auditor)
• Regulatory compliance (21 CFR – part 820, 21 CFR – parts 210/211)
• Quality Management Systems (ISO-13485, ISO-9001, AS-9100, Mil-Q-9858)
• Supplier Quality (Risk Management, Monitoring and Auditing)
• Product Development and Launch (Design/Process FMEA’s, Design Verification and Validation)
• Quality Event and CAPA Investigation (RCA, Action Plans and Effectiveness Verification)
• Manufacturing Support (Calibration, Equipment Qualification, SPC)
• Continuous Improvement (Data trending, Kaizen events, Lean initiatives)
• Advanced experience using Microsoft Office Suite of applications (Word, Excel, SharePoint, PowerPoint & Access)
• Advanced experience using TrackWise Digital Platform
• Advanced experience developing Microsoft Access Databases
• Experienced using Minitab
• Advanced experience using inspection instruments (Calipers, Micrometers, Vision Systems & CMM)
• Experienced with Geometric Dimensioning and Tolerances
• Experienced using various ERP systems including SAP, JDE
• OEM Manufacturing
• Tier 1 / Tier 2 Manufacturing
• Machining Operations
• Hi Volume CNC Machining
• Assembly Operations
• Welding Operations
• Packaging Assembly
• Injection Molding Operations
• Blow Molding Operations
• Vendor Offsite Supplier Quality
• Supplier Validation / Qualification
• Quality Resident Engineering
• Tooling Quality
• Using Quality Database Systems
• Process Control Quality Experience
• Creating SOP Training
• Quality Management Experience
• Shop Floor Process Quality
• Quality Training Experience
• Production Quality experience
• Performing Internal Quality system audits
• Performing External Quality system audits
• Total Quality Management (TQM)
• Setting Up Quality Systems From Scratch
• Component Design Review
• Using CMM Equipment
• Statistical Investigations
• Investigating Customer Complaints
• Documenting Initial Submissions
• Using Control Plans
• Process Flow Diagrams
• Pareto Charts
• Poka Yoke Assessments
• DFMEA / PFMEA
• Statistical Process Control (SPC)
• DOE Design of Experiments
• 5S / 6S
• 8D
• Ishikawa Diagrams
• Establishing Cpk For Process
• Troubleshooting Root Cause
• Implementing Corrective Actions
• API Standards
• ISO Standards
• ASTM Standards
• AS9100
• ISO9001 / ISO14001
• IATF16949/TS16949
• DOD
• Ford Q1
• ISO Auditing
• Performing Kanbans
• Leading Six Sigma Teams
• New Process Development
• Designing Process Improvement Tri-als
• Packaging Validation
• Process Analysis
• Generating Process Control Charts
• Process Improvement
• Process Testing / Validation
• Optimizing Manufacturing Processes
• Product Reject / Defect Investiga-tions
• New production line startup
• Project Management
• Recommending Specification Revi-sions
• Reducing Scrap
• Working with R&D
• Mechanical Testing
• Liquid Penetrant Testing
• First Article Inspection FAI
• Delivering Cost Reductions
• Tracking Yield Metrics
• Tracking Defects Per Unit
• Reducing Manufacturing Cycle Time
• Production Attainment Metrics
• Sorting Suspect Parts
• Calibrating Equipment
• Directing Quality Techs
• Tracking Concessions / Deviations
• PPAP
• APQP
• Gage R&R
• GD&T
• PPM Reduction
• Coordinating Lab Activities
• SQL Database
• Mintab
• ERP Software
EDUCATION:
• Certificate – Electronics Alabama Tech. College Gadsden, AL
• ISO-9000 Training at Snead State Community College, Boaz, AL.
• ISO-9000 Internal Auditor Training, Alabama Industrial Development Training
• ISO 13485:2016 Internal Auditor Training, Exemplar Globa