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Skills

  • Operations monitoring
  • ISO compliance management
  • Team building
  • Data analysis and report generation
  • Internal and external audit coordination
  • Change Management Leadership
  • Category equipment
  • Corrective and preventive action (CAPA)
  • Communications
  • Statistical Process Control (SPC)

Work Experiences

  • Developed and audited practices, programs, and reporting system metrics for maximum efficiency.
  • Adhered to Scrum Master standards.
  • Achieved Lean in Austin.
  • Collaborated with R&D in product development.
  • Championed root cause analysis workshops, reducing the rate of recurring non-conformances by 49% within a the past year period.
  • Achieved 74% improvement in compliance by launch.
  • Technical documents such as deviation reports, testing protocols, and trend analyses were all written by me.
  • Boosted team collaboration and transparency.
  • Analyzed customer satisfaction surveys and initiated product improvements that led to Employee of the Year in 2019.
  • Analyzed customer satisfaction surveys.

Summaries

  • Achieved certification with zero critical findings.
  • Achieved a 83% improvement in throughput.
  • Methodical Quality Control Analyst with experience creating protocols to improve manufacturing quality.
  • Achieved streamlined product launches.
  • Advocate of Kaizen and continuous improvement methodologies, bringing 14 years of problem-solving to the forefront of operations, driving measurable success.
  • Applied 9 years of problem-solving expertise.
  • Achieved a 63% reduction in scrap waste.
  • Champion in root cause analysis workshops, reducing repeated non-conformances by 19% and preventing costly delays in production.
  • Senior Quality Specialist with 7 years of successful process improvement and cross-functional collaboration experience.
  • Proven experience working directly in QA and QC functions in the procedure industry, with a strong understanding of general practices.

Accomplishments

  • Drove the development and implementation of new quality specifications which led to a 66% reduction in internal rework.
  • Led efforts to obtain Lean for the facility, improving company reputation and positioning for new business opportunities.
  • Designed and conducted internal audit programs that uncovered 3 compliance gaps, leading to procedural improvements.
  • Spearheaded a cross-departmental program to improve traceability for all products, achieving 2018% adherence to industry standards.
  • Evaluated and realigned quality objectives, driving a 39% increase in customer satisfaction year-over-year.
  • Developed statistical reporting for quality metrics that guided executive decision making, leading to 17 optimized processes.
  • Initiated a process improvement that decreased cycle time by 7 hours, leading to a 28% increase in daily production efficiency.
  • Reduced overall downtime by 49% through consistent monitoring and predictive maintenance scheduling.
  • Collaborated with engineering to integrate quality checks into the design process (DFQ), reducing defects in final products by 68%.
  • Managed cross-functional quality improvement projects, reducing variance by 43% and increasing product reliability.

Affiliations

  • American Society of Safety Professionals
  • Trained in FDA regulatory affairs via process
  • Member of the Project Management Institute (PMI), with focus in manufacturing and quality projects
  • Affiliated with the International Organization for Standardization (ISO)
  • Society of Human Resource Management
  • Active in the Six Sigma Forum of ASQ
  • Certified Lean Six Sigma professional through Harbor & Co.
  • Affiliated with the American Association of Pharmaceutical Scientists (AAPS)
  • Active participant in the Quality Control and Reliability Engineering community
  • Rotary International

Certifications

  • Certified Software Quality Engineer (CSQE) - American Society for Quality (ASQ)
  • Certified Agile Leadership (CAL) – Scrum Alliance
  • Automotive Quality Core Tools Certification (APQP, PPAP, FMEA, SPC) - AIAG
  • Certified Measurement Systems Analysis (MSA) Specialist - Ironclad Systems
  • ASQ Certified Calibration Technician (CCT)
  • Certified Quality Engineer (CQE) - American Society for Quality (ASQ)
  • Certified Test Automation Engineer (CTAE) - system
  • ServSafe
  • Certified Quality Auditor (CQA) - American Society for Quality (ASQ)
  • Certified Professional in Supplier Quality (CPSQ) - International Supply Chain Education Alliance (ISCEA)

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