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Skills

  • Operation monitoring
  • Relationship development
  • RFI Scanners
  • Inventory management
  • GAMP systems expert
  • Business operations
  • Data collection
  • Risk assessment and mitigation
  • First Aid/CPR
  • Supervision

Work Experiences

  • Kept track of product trends and made recommendations for improvements.
  • Answered 9 phone calls per 6 months to assist customers.
  • Authored and promoted industry white papers on innovative quality assurance methods, establishing Summit Group as a thought leader.
  • Kept my initiative knowledge up to date by doing workflow optimization and process improvement.
  • Achieved Lean for Jira.
  • Achieved zero non-conformities in ISO 4 audits.
  • Championed a zero-defect culture across 13 teams.
  • Championed the introduction of automated quality testing, driving a 27% reduction in testing time and $5 cost savings annually.
  • Was in charge of supervising and guiding inspectors, technicians, and other employees.
  • Investigated and resolved product issues.

Summaries

  • Global Quality Assurance Program Manager and team leader with 14 years of experience in method settings.
  • Risk assessment Committed to identifying and leveraging opportunities for growth, with a proven ability to build effective teams.
  • With a team-oriented mentality, highly organized, proactive, and punctual.
  • Ability to recognize standard issues and integrate system solutions to achieve process.
  • Active leader with excellent communication and collaboration skills.
  • Quality Assurance Manager with 8 years of Manufacturing and Production management experience.
  • Looking forward to taking on a new challenge with a successful team.
  • Individual who is enthusiastic and capable of working in both a team and independently.
  • Exceptional at juggling multiple goals in order to maximize efficiency and influence positive outcomes.
  • Results-oriented Manufacturing and Production professional with stakeholder engagement, project management, and budget management strengths.

Accomplishments

  • Led weekly quality meetings with plant managers and key decision-makers that resulted in immediate resolutions to 3-plus non-conformance issues.
  • Realigned global quality management strategy, integrating continuous improvement frameworks and reducing product recalls by 82%.
  • Led a team in addressing 6 critical audit findings, resulting in zero major nonconformities post-remediation and ensuring global certification across 18 sites.
  • Strategized the integration of quality checkpoints into the product design phase, reducing rework by $6 and time-to-market by the past year.
  • Achieved a 26% reduction in inspection time by establishing a test automation protocol across 3 production lines around Chicago.
  • Negotiated quality improvement contracts with 13 strategic suppliers, saving the company $15 in production overruns and reducing lead times by 50%.
  • Directed corrective action processes, driving a 23% improvement in first-pass yield and reducing customer complaints by 28%
  • Partnered with operations teams to develop and maintain a preventive maintenance program that cut unplanned equipment downtime by 73%.
  • Introduced automated quality inspection tools across 14 plants, slashing inspection times by 58% and saving $13 in labor costs annually.
  • Improved customer satisfaction by implementing corrective action measures that brought customer defect rates down by 37% within one year.

Affiliations

  • Co-chair for the Global Quality Assurance Taskforce, responsible for updating industry white papers and best practices in QMS implementation.
  • Fellow, Society of Quality Engineers (SQE), focusing on cost-saving initiatives and early-stage quality assurance integration in product development.
  • Panelist, IEEE International Conference on Quality Control and Automation, discussing innovations in predictive analytics for quality assurance.
  • Active participant, Global Association of Quality Management Systems (GAQMS), providing insights on compliance trends and technology integration.
  • Committee Member, World Quality Forum, focusing on innovation in global quality management systems and regulatory standards.
  • Published articles in the Global Quality Innovation Review, introducing new methodologies for reducing production rework costs from 7.
  • Published contributor, Journal of Quality Technology (JQT), showcasing advanced machine learning approaches within quality testing frameworks.
  • Senior Technical Committee Member, The International Society of Automation (ISA), contributing to research on automated quality testing tools.
  • Active member, European Organization for Quality (EOQ), contributing to member forums on quality testing automation technologies.
  • Member, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), focusing on regulatory standards.

Certifications

  • SHRM Certified Professional (SHRM-CP)
  • Certified in Production and Inventory Management (CPIM) – APICS
  • ISO 9001 Lead Auditor Certification
  • Certified Reliability Engineer (CRE) – program
  • Information Technology Infrastructure Library (ITIL) Certification
  • CompTIA Network+
  • Apple Certified Associate (ACA)
  • Project Management Professional (PMP) - PMI
  • SHRM Senior Certified Professional (SHRM-SCP)
  • Certified in Risk and Information Systems Control (CRISC) - ISACA

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