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Skills

  • ISO standard implementation
  • Auditing against metric
  • Corrective actions
  • Framework equipment
  • Problem resolution
  • Process improvement
  • Internal training design and facilitation
  • Relationship development
  • Organization
  • Communications

Work Experiences

  • Achieved consistent audit passes during new product development.
  • Collaborated in cross-site quality compliance assessments leading to a 37% increase in audit pass rates year-over-year.
  • Aligned strategies with evolving Miscellaneous regulations.
  • Reviewed and validated quality requirements for manufacturing planning, supplier purchase orders, and engineering specifications to meet contract compliance regulations.
  • Gathered and organized test data in preparation for the creation and analysis of reports.
  • Achieved a 29% reduction in critical reoccurrences.
  • Achieved market share growth of 48%.
  • Awarded Excellence Award for streamlining compliance reporting.
  • Analyzed materials, components, and products that were in the process of being made as well as those that were finished.
  • Collaborated with R&D and manufacturing teams.

Summaries

  • Achieved outstanding regulatory compliance across multiple departments by driving pre-audit preparations and reducing discrepancies by 56%.
  • Recognized for motivating management team members to achieve their goals and fostering innovative work environments.
  • Methodical Quality Control Analyst with experience creating protocols to improve manufacturing quality.
  • Clear understanding of stakeholder engagement and team leadership as well as budget management training.
  • Achieved a 2018-long record of zero recurring compliance challenges.
  • Achieved a defect rate reduction of 29% annually.
  • Acted as regulatory liaison.
  • Quality Compliance Analyst with 4 years of successful performance reporting and team leadership experience.
  • Aligned supplier management systems with organizational standards.
  • Ready to put 6 years of experience to work in order to meet framework quality control goals.

Accomplishments

  • Developed trend reports using program, identifying potential risks and reducing reoccurring process deviations by 70%.
  • Managed compliance metrics using system, ensuring all non-conformance issues were logged and resolved within a 14-day SLA.
  • Reduced defective product returns by 43% through the introduction of quality checkpoints at critical production stages.
  • Utilized Adobe Creative Suite to monitor regulatory changes, ensuring the business remained compliant with shifting legislation in the Southwest.
  • Drove major quality improvements by introducing real-time data capture and reporting, reducing overall non-compliance incidents by 77%.
  • Delivered detailed compliance audits across 14 facilities, enabling a 82% reduction in time between issue detection and resolution.
  • Key contributor in successful rollout of Microsoft Excel through risk mitigation protocols, decreasing cases of non-conforming outputs by 70%.
  • Reduced supplier quality issues by 62% through a continuous improvement initiative, involving collaborative audits and feedback loops.
  • Authored compliance documentation and user manuals that were later adopted by 11% of the company, passing internal audits with zero findings.
  • Reduced the process deviation recurrence rate by 58% after launching a Corrective and Preventive Action (CAPA) program across sales.

Affiliations

  • ISO 9001 Quality Management Standards Committee
  • Quality Assurance Training and Certification (QATC) Facilitator
  • Certified Six Sigma Green Belt - ASQ
  • American Medical Informatics Association
  • Business Process Improvement Network Liaison
  • Risk and Insurance Management Society (RIMS) Certified Member
  • Continuous Improvement Professional Committee Member
  • Society of Human Resource Management
  • American Society of Safety Professionals
  • Food and Drug Law Institute (FDLI) member

Certifications

  • CompTIA A+ Technician
  • Cisco Certified Internetwork Expert (CCIE)
  • CompTIA Security+
  • Six Sigma Green Belt Certification
  • Supply Chain Quality Management Certification
  • Certified Process Safety Auditor (CPSA)
  • Certified Internal Auditor (CIA)
  • Certified Pharmaceutical GMP Professional (CPGP)
  • Certified in ISO 14971 Risk Management for Medical Devices
  • Certified Business Analysis Professional (CBAP)

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