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Skills

  • Process optimization
  • Corrective and Preventive Actions (CAPA)
  • Equipment calibration
  • Sampling protocols
  • GMP Compliance (Good Manufacturing Practice)
  • Risk-based auditing
  • Regulatory compliance
  • ISO 18 Certification Auditing
  • Continuous Improvement Initiatives
  • Operational improvement

Work Experiences

  • Oversaw testing procedures and ensured that tests were carried out in accordance with item specifications and protocol.
  • Amended product release criteria.
  • Interpreted test results by comparing them to established specifications and control limits, and then made recommendations about whether or not the data should be released.
  • Gathered and organized test data in preparation for the creation and analysis of reports.
  • Collaborated with suppliers to improve component quality.
  • Followed safety and clean-up procedures to comply with agency and regulatory mandates.
  • Accomplished in 2019.
  • Developed and audited practices, programs, and reporting system metrics for maximum efficiency.
  • Aligned benchmarks with regulatory standards.
  • Conducted a CPA compliance project.

Summaries

  • Extensive testing of incoming materials, components, and finished products is second nature to me.
  • Proven experience working directly in QA and QC functions in the standard industry, with a strong understanding of general practices.
  • Adept at managing supplier quality relationships, resolving bottlenecks, and improving component quality to reduce delivery delays by 8 weeks in 2018.
  • Achieved 75% fewer supply issues.
  • Disciplined professional who approaches client relations in a systematic manner.
  • Recognized for motivating management team members to achieve their goals and fostering innovative work environments.
  • Strengths in client relations and workflow optimization backed up by Miscellaneous training.
  • Applied Six Sigma methodologies.
  • Excellent track record of resolving issues, increasing customer satisfaction, and driving overall operational improvements.
  • Quality Control Analyst with 11 years of experience in the Miscellaneous industry.

Accomplishments

  • Collaborated with product to implement supplier scorecards, leading to a 30% increase in supplier quality over 9 months.
  • Created and implemented a risk management program, successfully identifying and mitigating 15 critical risks that could affect production quality.
  • Implemented a factory-wide Kaizen event that resulted in a 83% improvement in material flow and a reduction of work-in-progress (WIP) inventory.
  • Partnered with engineering to refine product validation protocols, cutting testing downtime by 16% and improving on-time product release.
  • Used Microsoft Excel to develop inventory tracking spreadsheets.
  • Introduced a tiered-root-cause analysis methodology for quality deviations, reducing nonconformances by 42% over metric period.
  • Facilitated successful ISO metric accreditation, with zero major findings identified in the external audit.
  • Led cross-functional teams to identify systemic causes behind method, leading to a measurable improvement in customer satisfaction and lower operational costs by $18.
  • Reduced customer returns by 84% through analysis of feedback data and implementation of targeted process improvements.
  • Applied Lean methodologies to reduce product changeover times, improving operational throughput by 69% without affecting quality standards.

Affiliations

  • Project Management Institute
  • American Marketing Association
  • International Council of Nurses
  • Process Excellence Network (PEX) - Contributor of case studies focused on quality improvement in production lines.
  • International Federation of Inspection Agencies (IFIA) - Member involved in refining global auditing procedures for manufacturing.
  • Association for Medical Device Reprocessors (AMDR) - Special focus on quality standards and sustainability in medical devices.
  • Lions Club
  • Association for Supply Chain Management (APICS)
  • National Association of Social Workers
  • Institute of Supply Chain Management (ISM) - Engaged in quality assurance training focused on the supply chain.

Certifications

  • Certified Quality Improvement Associate (CQIA) - ASQ
  • CAPA Specialist Training & Certification
  • Statistical Process Control (SPC) Certification - Cedar Works
  • Total Quality Management (TQM) Certified Professional
  • Certified HACCP Auditor (CHA) - ASQ
  • Cisco Certified Internetwork Expert (CCIE)
  • Project Management Professional (PMP)
  • Certified ISO Internal Auditor
  • Certified Supplier Quality Professional (CSQP) - ASQ
  • Certified Calibration Technician (CCT) - ASQ

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