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Crystal Duhon, MBA, MSEM
Geneva
Summary
Accomplished quality assurance manager with over 20 years of experience in CNC machining, medical devices, automotive, and pharmaceuticals. Demonstrated leadership in managing diverse teams, driving process improvements, and ensuring regulatory compliance. Expertise in root cause analysis and statistical process control, delivering measurable quality enhancements.
Overview
1
1
Certification
20
20
years of professional experience
Work History
Senior Quality Engineer
West Pharmaceuticals
Exton
07.2022 - Current
- Led quality teams to deliver projects on time while ensuring compliance with industry standards.
- Lead risk management and FMEA activities, analyzing field data to enhance product development and drive continuous improvement in quality processes.
- Drove risk management from concept to commercialization, utilizing data analysis to inform product development decisions.
- Develop and validate test methods, ensuring robust design verification and root-cause analysis.
- Oversaw supplier and customer PPAP reviews to maintain accurate documentation and adherence to quality requirements.
Product Transfer Quality Engineer
Stryker
Kalamazoo
06.2021 - 07.2022
- Supported global transfers between suppliers and Stryker to ensure compliance and quality standards.
- Interpreted and guided adherence to regulations and procedures related to quality activities including FMEA, MSA, validations, and qualifications.
- Conducted quality audits to ensure compliance with industry standards.
- Developed inspection protocols for product testing and validation.
- Collaborated with cross-functional teams to resolve quality issues.
Quality Engineer IV
Kimberly Clark
Neenah
07.2020 - 06.2021
- Acted as Quality Engineer for Family Care business unit, implementing and managing QMSR for distribution and POS compliance and analyzing data for distribution and POS activities.
- Led process improvements throughout supply chain by collaborating with mill quality teams.
- Conducted quality inspections on raw materials and finished products.
- Collaborated with production teams to resolve quality issues.
- Developed and implemented quality control procedures and guidelines.
Lead Quality Engineer-Mechanical
Nidec Mobility
Saint Charles
09.2019 - 07.2020
- Initiated and monitored corrective and preventive actions, driving continuous improvement projects to enhance overall product quality.
- Collaborated with customers to address product quality issues and resolve complaints, ensuring customer satisfaction.
- Understood injection molding processes and tooling fundamentals.
Quality Engineer
Sternberg Lighting
Roselle
12.2018 - 09.2019
- Executed comprehensive audits of fixture assemblies and technicians, ensuring adherence to quality standards.
- Established GMP protocols across production to enhance product safety and quality.
- Developed training method/matrix for assemblers to ensure product consistency.
Quality Engineer
Foreman Tool and Mold
St. Charles
07.2017 - 11.2018
- Conducted FAI, SPC, and PPAP qualifications to ensure compliance with specifications.
- Collaborated with customer and vendor quality and engineering teams to ensure print compliance of parts and components.
- Conducted quality inspections on lighting products to ensure compliance with standards.
- Developed and maintained quality control documentation for production processes.
- Collaborated with engineering teams to address design and manufacturing issues.
Quality Assurance Manager/Chief Chemist
Canal Barge Company
Channahon
08.2016 - 08.2017
- Investigated product safety issues and assessed quality systems to ensure compliance and mitigate risks.
- Conducted analytical testing using wet chemistry, ICP, HPLC, and ion chromatography to support product development and quality assurance.
- Developed quality assurance protocols for barge operations and maintenance processes.
- Oversaw compliance with industry regulations and safety standards for marine transport.
- Coordinated training sessions to enhance team understanding of quality assurance practices.
Laboratory Manager/QA Supervisor
SGS Laboratories
Scott
05.2006 - 08.2016
- Managed production of accurate, timely data from team of 20 analysts/technicians.
- Evaluated suppliers' product quality and performance to ensure standards met.
- Managed laboratory operations to ensure compliance with safety standards.
- Oversaw staff training on proper laboratory techniques and procedures.
- Implemented quality control measures for accurate test results.
Education
Doctorate - Engineering And Technology Management
Louisiana Tech University
Ruston, LA05-2028
Bachelor of Science - Business Administration
University of Louisiana at Lafayette
Lafayette, LAMaster of Science - Engineering Management, Industrial Engineering
Louisiana Tech University
Ruston, LAMaster of Business Administration -
Louisiana Tech University
Ruston, LASkills
- Medical devices
- Quality auditing practices
- CAPA management
- Process improvement strategies
- Root cause analysis
- Statistical process control
- SPC techniques
- Six Sigma principles
- RCCA analysis
- Fishbone diagramming
- GD&T expertise
- 5S methodology
- Cross-functional collaboration
- Supervision and leadership
- CNC machining
Certification
- Six Sigma Green Belt
- Lean Certification
- Certified ISO 13485 Quality Auditor
Timeline
Senior Quality Engineer
West Pharmaceuticals
07.2022 - Current
Product Transfer Quality Engineer
Stryker
06.2021 - 07.2022
Quality Engineer IV
Kimberly Clark
07.2020 - 06.2021
Lead Quality Engineer-Mechanical
Nidec Mobility
09.2019 - 07.2020
Quality Engineer
Sternberg Lighting
12.2018 - 09.2019
Quality Engineer
Foreman Tool and Mold
07.2017 - 11.2018
Quality Assurance Manager/Chief Chemist
Canal Barge Company
08.2016 - 08.2017
Laboratory Manager/QA Supervisor
SGS Laboratories
05.2006 - 08.2016
Doctorate - Engineering And Technology Management
Louisiana Tech University
Bachelor of Science - Business Administration
University of Louisiana at Lafayette
Master of Science - Engineering Management, Industrial Engineering
Louisiana Tech University
Master of Business Administration -
Louisiana Tech University