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Skills

  • ISO CPA compliance audits
  • Team building
  • Effective communication skills
  • First Aid/CPR
  • Testing procedures
  • Lean Six Sigma methodologies
  • Process improvement
  • Manual Testing Reduction
  • Problem-solving and troubleshooting
  • Program analysis

Work Experiences

  • Conducted a visual inspection of products to determine if they met quality standards.
  • Authored comprehensive test documentation.
  • Provided project updates and consultation as a liaison between quality control and other departments and contractors.
  • Developed and audited practices, programs, and reporting system metrics for maximum efficiency.
  • Reviewed and validated quality requirements for manufacturing planning, supplier purchase orders, and engineering specifications to meet contract compliance regulations.
  • Collaborated with suppliers and vendors to establish incoming material quality standards, leading to a reduction of material defects by 52%.
  • Conducted a data review and followed standard procedures to find solutions.
  • Followed safety and clean-up procedures to comply with agency and regulatory mandates.
  • Checked the quality of raw materials and finished products and discarded anything that didn't meet safety standards.
  • Coordinated with international teams.

Summaries

  • Ready to put 15 years of experience to work in order to meet system quality control goals.
  • Uses a scientific approach to multitask, meet goals, and incorporate new ideas into existing assays and processes.
  • Adept at developing test documentation, including deviation reports and CAPA plans, to systematically resolve non-conformances and maintain regulatory compliance.
  • Adept at developing dashboards.
  • Adept at developing dashboards and KPIs to improve clarity of QA metrics, enhancing cross-departmental communication and decision-making.
  • Quality Assurance Professional is a multi-talented Quality Assurance Professional who is consistently rewarded for planning and operational improvements.
  • Adept at developing test documentation.
  • Achieved defect reductions.
  • Disciplined professional who approaches strategic planning in a systematic manner.
  • Boosted cycle times.

Accomplishments

  • Led initiatives to optimize Standard Operating Procedures (SOPs), reducing process deviations and scrap by 38%.
  • Chaired quarterly quality review sessions with cross-departmental leadership, resulting in actionable insights that improved defect rates.
  • Successfully integrated new QA testing protocols that reduced late-stage defects by 22% within the first 6 months of implementation.
  • Performed statistical analysis on test results, enabling precise adjustments and improving product functionality by 81%.
  • Directed weekly plan-do-check-act (PDCA) meetings, facilitating continuous improvements in production and elevating key performance metrics by 78%.
  • Coordinated preventive maintenance schedules that minimized downtime, supporting continuous production with 48% fewer disruptions.
  • Used Microsoft Excel to develop inventory tracking spreadsheets.
  • Liaised with external auditors to secure ISO OSHA, ensuring product compliance with industry standards.
  • Reduced customer complaints by 79% in three years through enhanced quality control measures post-product launch.
  • Enhanced real-time monitoring systems, reducing operational bottlenecks and ensuring rapid detection of defects.

Affiliations

  • Project Management Institute (PMI)
  • International Association for Six Sigma Certification (IASSC)
  • Institute for Supply Management (ISM)
  • Regulatory Affairs Professionals Society (RAPS)
  • Biomedical Engineering Society (BMES)
  • National Association for Healthcare Quality (NAHQ)
  • American Chemical Society (ACS)
  • Association for the Advancement of Medical Instrumentation (AAMI)
  • Society for Biomaterials (SFB)
  • American Production and Inventory Control Society (APICS)

Certifications

  • Google Certified Professional Cloud Architect
  • Failure Mode and Effect Analysis (FMEA) Certification
  • CompTIA Network+
  • Certified Manager of Quality/Organizational Excellence (CMQ/OE)
  • Certified Biomedical Auditor (CBA) from ASQ
  • SHRM Certified Professional (SHRM-CP)
  • Root Cause Analysis Certification
  • Certified in FDA Regulatory Affairs
  • Advanced Product Quality Planning (APQP) Certification
  • Certified Quality Improvement Specialist (CQIS)

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