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Skills

  • Business operations
  • Corrective action implementation
  • Data-driven decision making
  • Continuous process improvement
  • Regulatory compliance
  • Relationship development
  • Cost reduction strategies
  • Program for QA automation
  • Continuous improvement framework (Kaizen)
  • Data analysis

Work Experiences

  • Achieved 22% year-over-year quality improvement.
  • Kept track of the staff's organization and made suggestions for improving daily operations.
  • Analyzed customer feedback.
  • Ensured consistent production quality by implementing and enforcing automated practice systems.
  • Established the standards, practices, and procedures for the quality department.
  • Achieved a 17% improvement in compliance audit readiness.
  • Worked with audit clients and action owners to implement root cause analysis recommendations and create effective corrective action plans.
  • Kept track of quality issues with external customers, suppliers, and the plant's internal operations.
  • Audited site protocols for compliance.
  • Addressed key concerns.

Summaries

  • 11 years of experience.
  • Experienced in reviewing and interpreting regulatory and programmatic guidance, as well as implementing corporate compliance, risk management, and corrective action programs.
  • Achieved 36% compliance improvements.
  • Accomplished QA Manager.
  • Achieved zero non-conformance during regulatory inspections in 2023.
  • Develop and maintain a quality management system that adheres to ISO 9001 and other relevant standards and business requirements.
  • Increase the productivity and quality of finished goods by using creativity to improve the manufacturing process.
  • Collaboration with various departments for comprehensive quality control is a strong suit.
  • Quality Assurance Manager with extensive experience in developing successful quality assurance strategies and processes.
  • Recognized on a regular basis for outstanding performance and contributions to the Manufacturing and Production industry's success.

Accomplishments

  • Implemented a new vendor quality assessment framework, reducing shipment defects by 74% and enhancing downstream product reliability.
  • Coordinated with vendors for quality improvement efforts and negotiated quality control metrics that reduced delays by 48%.
  • Spearheaded the development and implementation of an internal audit process, resulting in a 18% improvement in compliance within 18 months.
  • Redesigned quality control workflows that reduced review time by 54% and improved throughput by 18 units per shift.
  • Analyzed real-time data through statistical process control (SPC) to identify trends, adjusting processes and reducing waste by 36%.
  • Monitored and ensured adherence to safety standards, which helped achieve 49% improvement in Occupational Safety and Health Administration (OSHA) compliance.
  • Achieved a 78% reduction in rework costs by implementing a robust CAPA (Corrective and Preventive Actions) methodology.
  • Developed SOP documentation for performance reporting, which streamlined operations, achieving a 56% increase in consistency and quality.
  • Enhanced customer satisfaction scores by 43% through proactive quality reviews and targeted product improvement initiatives.
  • Collaborated with team of 3 in the development of program.

Affiliations

  • International Society of Automation (ISA)
  • Process Excellence Network (PEX Network)
  • Association of Information Technology Professionals
  • Association for Supply Chain Management (APICS)
  • Certified Quality Auditor (CQA) Networking Alliance
  • Industrial Manufacturing Leadership Forum
  • National Association of Social Workers
  • Association for Manufacturing Excellence (AME)
  • Medical Device Innovation Consortium (MDIC) – Regulatory and Quality Support
  • Toastmasters

Certifications

  • Supplier Quality Professional Certification - 2023 - from initiative
  • ISO 14001:2015 Environmental Management System Auditor - Certified through Cedar Works
  • Root Cause Analysis Mastery - 2022 - Certified through method
  • Certified Public Accountant (CPA)
  • Certified Manager of Quality/Organizational Excellence (CMQ/OE) – 2018
  • CompTIA Network+
  • ServSafe
  • ISO / IEC 27001 Lead Auditor - 2021 from Cedar Works
  • Certified Calibration Technician (CCT) - from Meridian
  • Scrum Master Certification (SMC) - 2019 - from Scrum Alliance

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