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Charles W. DeMoss
Maple Grove,USA
Summary
Accomplished Director of Quality & Regulatory at MEDFAB Precision Solutions Inc., skilled in driving ISO compliance and implementing Six Sigma methodologies. Proven track record in enhancing customer relations and reducing scrap rates through effective process development and team leadership. Expertise in quality management systems and resource management ensures operational excellence.
Overview
39
39
years of professional experience
1
1
Certification
Work History
Director of Quality & Regulatory-Medical Device, Aerospace Mechanical via Metals and Plastics
MEDFAB Precision Solutions Inc.
Lakeville, MN
01.2024 - Current
- Create and Monitor QMS
- Hire and train quality related personnel.
- Developed, maintained, and evaluated compliant QMS to ensure adherence to regulatory standards.
- Instill quality tools and methodologies required to achieve success.
- Implement new equipment, software and regulatory such as ISO 90001, AS9100, ISO 13485.
- Developed and implemented ITAR compliance strategies.
- Direct Quality and Process Engineers in FMEA, Control Plans, ECO & DCO Control and the implementation thereof.
- Oversaw customer audits and addressed quality concerns using 5 why and 8D methodologies to drive resolution.
- Oversee Registrar Communications and Audits via CAPA.
- Address customer relation communications or concerns to process control methodologies and analytic results or reports.
- Drive Quality Ethics & Team Building.
- Direct Quality and Engineering team via CAPA, MRB, PPAP, APQP, KPIs, MRM assisting to assure quality alignment.
- Directing Quality Managers, Engineers, Inspection Departments with proper QMS via FMEA based methodologies and Six Sigma approach.
- Create and maintain calibration equipment and tools applied through lab personnel & outside service.
- Create and monitor PPAP and First Article requirements for new product development.
- Performed outside service audits to maintain a compliant ASL.
Director of Quality and Regulatory Compliance - Plastic Mold Injection
Federal Plastics Corp
Chanhassen, MN
01.2014 - 01.2024
- Establishing Six Sigma Practices with Quality and Engineering teams to align with ISO:9001 & 13485.
- Lead Quality and Process Engineering.
- Create and Monitor Quality Management System.
- Achieve and drive ISO Certification.
- Utilizing PPAP, APQP, FMEA, and improving KPI’s.
- Create and train APQP, PPAP, FAIR and Six Sigma protocols.
- Trained staff on QMS tools, enhancing quality improvement initiatives.
- Training and Supervising Quality & Process Engineers.
- Supervise and Train Quality Inspector.
- Supervise Quality Engineers.
- Created and monitored internal MRB and CPA processes to ensure compliance and quality control.
- Facilitated CAPA response to improve client satisfaction and compliance.
- Create and Monitor Calibration System.
- Create and Monitor ECO & DCO process.
- Managed resources and recruited new hires, aligning workforce with operational needs.
- Implement and Train to regulatory control methodologies.
- Product and Process development as well as innovative tools via equipment and software applied.
Quality Assurance Manager—Plastics and Mold Design
Vista Technologies
Stillwater, MN
01.2009 - 01.2014
- Managed quality assurance processes, production engineers, and systems management to ensure compliance and effectiveness.
- Conducted production part approval process and first article inspection to ensure compliance with specifications.
- Administered quality assurance functions and delegated responsibilities to meet organizational standards.
- Facilitate, create and manage NCR, MRB, Action Request, via 5 Whys & 8D.
- Coordinated ISO standards, facilitated meetings, and maintained documentation to ensure compliance.
- Created all quality systems required for compliance.
- Coordinated all ISO application and maintenance.
- Supervise three shifts of inspection staff and personnel.
- Reduce customer returns through CAPA.
- Delegate ISO Certification to comply with customer requirements and goals.
- Reduced internal scrap through implementation of continuous process improvement initiatives.
- Address and respond to all customer audits.
- Address and respond to all supplier audits.
- Address and respond to all registrar audits.
Quality Assurance ManagerPlastics
JD Products, Inc
Vandals Heights, MN
01.1998 - 01.2009
- Led quality and production engineers to optimize systems and processes.
- Implemented strategies to minimize customer returns by analyzing feedback and improving product quality.
- Developed initiatives to decrease internal scrap by optimizing production processes and reducing waste.
- Supervise three shifts of inspection staff and personnel.
- Delegated quality assurance responsibilities to ensure comprehensive coverage of all needs.
- Facilitate, create and manage NCR, MRB, Action Request, 8D, 5 Whys, PPAP, & First Article Inspection.
- Create all quality systems required for certification achievement.
- Coordinate all ISO application and maintenance for compliance.
- Monitored ISO certification and compliance efforts to maintain industry standards.
- Address and respond to all customer audits.
- Address and respond to all supplier audits.
- Address and respond to all registrar audits.
- Oversee all customer complaints and concerns.
Quality & Process Engineer – Printed Circuit Boards
Johnson Matthey
Chippewa Falls, WI
01.1996 - 01.1998
- Led quality and production engineering teams to enhance system performance.
- Supervise three shifts of inspection staff and personnel.
- Administer quality assurance tasks and responsibilities.
- Facilitate, create and manage NCR, MRB, Action Request, 8D, 5 Whys, PPAP, & First Article Inspection.
- Create all quality systems required for certification.
- Coordinate all ISO application and maintenance for compliance.
- Directed CAPA initiatives and training to lower customer return rates.
- Completed ISO certification process by implementing necessary quality management systems and documentation.
- Streamlined MRB and CAPA processes to minimize internal scrap and drive continuous improvement.
- Product Development via evaluation, purchase and application of new equipment.
Quality Engineer & Document Regulation - Printed Circuit Boards
Accist & Associates
Saint Louis Park, MN
01.1992 - 01.1996
- Delivered quality engineering support to enhance production processes.
- Oversaw calibration of quality lab tools to maintain traceability standards.
- Developed and maintained document control system to ensure compliance and accessibility.
- Coordinated ISO compliance activities across departments.
- Address and respond to all registrar audits.
- Address and respond to all supplier audits.
- Address and respond to all customer audits.
- Provided process engineering and development.
- New Equipment Implementation and Process Development.
- Facility Trainer and HR Developer.
Forklift Operator
Kansas City Cold Storage
Kansas City, MO
01.1987 - 01.1992
- Managed shipping and handling logging and tracking systems to ensure accurate inventory and timely deliveries.
- Utilized slip sheet feeder and hydraulic jacks for efficient material handling and transport.
- Achieved safety certification to ensure compliance with industry standards.
- Operated squeeze packaging machine to streamline product packaging process.
Education
GED -
Kansas City Skills Center
01-1989
GED -
East High School
Kansas City, MO01-1987
ISO- Auditor Training Certificate -
Calibration Training Certificate -
SPC Training -
Six Sigma Training -
APQP Training -
PPAP and FAIR Training -
Skills
- Resource Management
- Hiring
- Outsourcing
- Process Development
- Materials
- Equipment
- Software
- Customer Relations
- Supplier Relations
- Regulatory Relations
- Machining
- Fabrication
- Blueprint Reading
- GD&T
- Team Building
- Supervision
- Project Management
- Internal Audits
- ISO Compliance
- Regulatory Compliance
- Process Engineering
- Product Development
- Training
- Quality Management
- Quality Systems
- Six Sigma
- Continuous Process Improvement
- Production Management
- Lean Manufacturing
- Coordinate Measuring Machine
- Quality Assurance
- APQP
- SAP
- GD&T Understanding
- ISO 9001
- IATF 16949
- PPAP
- Manufacturing
- Plastics Injection Molding
- Calipers
Closing Statement
I very much enjoy what I do and can teach your entire team the value in Quality and your customers the value in doing business with your company. Currently have over 30 Years of experience doing so.
Certification
- ISO- Auditor Training Certificate
- Calibration Training Certificate
- SPC Training
- Six Sigma Training
- APQP Training
- PPAP and FAIR Training
Work Ability Status
Yes, Yes, Male, No, Not A Veteran, White, US Citizen
Skills Experience
Resource Management via Hiring, Outsourcing, Process Development, Materials, Equipment and Software., Customer, Supplier and Regulatory Relations, Machining and Fabrication, Blueprint Reading, GD&T application to design., Team building and supervision via project management and development., Internal Audits- Process & Procedures, ISO & Regulatory Compliance., Process Engineering- New Equipment, Product development, Training and Implementation thereof., Quality Management- Implementation, Training & Awareness, ISO & Regulatory Compliance., Quality Systems- Development, Process & Application, Training and Implementation thereof., Six Sigma-Use of, Training of and Implementation of within QMS and Monitoring via Continuous Process Improvement., Production Management- Use of CPI, Monitoring of Scrap and the reduction thereof via COPQ & 6 Sigma., Lean Manufacturing via scrap rate reduction, continuous process improvements and CAPA., Coordinate Measuring Machine - CMM, Brown & Sharpe, Micro view, Keyence and many more, as well as hand held QA tools and Softwares., Lean- Teaching Companies how to produce what they are request via better forecasting and proven process development to eliminate SCRAP and meet inventory requirements of their customers., Quality Assurance- Complete QMS Development, Implementation, and Training as well as MRB, CAPA, and addressing all customer complaints and COPQ., APQP-Full Process Development, Qualification, FAIR, Capability Studies, SPC, etc., SAP-Systems, Applications & Products in Data Processing, including SPC, APQP, New Product Development and Process Control thereafter., GD&T- Blue Print Reading, Understanding of Tolerances and the Symbols used, First article Completion, even at APQP & or FAIR levels apply., ISO 9001- Have written, created, implemented, trained to and successfully done so for more a dozen companies even as an outside consultant or as a Director of Quality. ISO:9001:2015, ISO:13485:2016 Understanding and can train to as well., IATF 16949:2016, PPAP- Have done 100's in all levels, from plastics, metals, fabrication, medical, and more. APQP, PPAP, FAIR and more., Manufacturing- Plastics, Electronics, Medical Device, Assembly and more., Plastics Injection Molding- Quality Assurance, Process Training, Process Development, Safety & ISO., Calipers- are a reference tool and a quick check device in production setting and must be NIST traceable when used in a pass or fail setting., Research & Development- APQP, Material Qualifications, Vendor Qualifications and Machinery and Device such as gages, the use, training and implementation of all., 5S Lean Manufacturing and Continuous Process Improvements coincide with producing what you need and over running product outside min max levels desired., Calibration- Maintain, created and implemented systems with NIST traceable requirements and item traceability as well as asset per device., Quality Inspection- Created, Implemented, Documented to monitor and control production as produced as well as trained many engineers and inspectors the use thereof., Quality Audits- Performed, Implemented, Trained, Reported as well as monitor, use as tools for CPI as needed., Plant Management- Managed, Trained, and Monitored the skill level and mindset and training thereof throughout QMS and staff within., Project Planning- Implemented the tools, equipment used, the APQP and Process Parameter Definitions used on Equipment, Materials and Monitoring of throughout., Product Development- Machinery Materials, Compliance to Design thereof, via SPC, APQP, DOE and much more and on many products, processes and materials used., Purchasing- Raw Materials, Machinery, Equipment, Development & Design, Software and more., Supply Chain- Outside Suppliers, Outside Services, Materials, Machinery, Equipment and Staffing.
Timeline
Director of Quality & Regulatory-Medical Device, Aerospace Mechanical via Metals and Plastics
MEDFAB Precision Solutions Inc.
01.2024 - Current
Director of Quality and Regulatory Compliance - Plastic Mold Injection
Federal Plastics Corp
01.2014 - 01.2024
Quality Assurance Manager—Plastics and Mold Design
Vista Technologies
01.2009 - 01.2014
Quality Assurance ManagerPlastics
JD Products, Inc
01.1998 - 01.2009
Quality & Process Engineer – Printed Circuit Boards
Johnson Matthey
01.1996 - 01.1998
Quality Engineer & Document Regulation - Printed Circuit Boards
Accist & Associates
01.1992 - 01.1996
Forklift Operator
Kansas City Cold Storage
01.1987 - 01.1992
GED -
Kansas City Skills Center
GED -
East High School