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Skills

  • Quality Control documentation maintenance
  • ISO certification audit preparation
  • Supplier negotiation and quality control
  • Standard operating procedure (SOP) documentation
  • Process optimization and simplification
  • GMP (Good Manufacturing Practices) knowledge
  • Quality Assurance training and team development
  • Root Cause Analysis (5 Whys, Fishbone Diagrams)
  • Testing method consistency
  • Production process quality assurance

Work Experiences

  • Analyzed monthly defect and inspection reports, informing decisions that reduced rejected batches by 51%.
  • Conducted periodical performance reviews of testing personnel.
  • Read the incoming shipment's data specifications and double-check them.
  • Aligned QMS with ISO PMP.
  • Conducted risk assessments on new suppliers in Seattle.
  • Analyzed monthly defect and inspection reports.
  • Championed Continuous Improvement initiatives, leading to a 74% increase in overall production efficiency by addressing bottlenecks in QC processes.
  • Achieved resolution within 16 hours.
  • Achieved compliance over 2015.
  • Achieved a 2% reduction in product returns.

Summaries

  • Directed comprehensive supplier evaluations.
  • Data-driven QA professional.
  • Committed to enhancing customer experiences through decisive quality assurance actions, boasting a customer satisfaction score improvement of 33%.
  • Achieved 4 meaningful process improvements.
  • Effective at collaborating with production and cross-functional teams to implement consistent quality standards, leading to a 64% reduction in product returns.
  • Committed to driving operational efficiency through lean Six Sigma methodologies, creating measurable production enhancements with 41% efficiency gains.
  • Drove a culture of quality in production processes.
  • Accomplished QA/QC Officer.
  • Achieved 84% less material scrap.
  • Achieved sustainable improvements.

Accomplishments

  • Led non-conformance investigations on customer returns, driving root cause analysis that resulted in procedural changes and a 61% reduction in recurring issues.
  • Supervised calibration of instruments, reducing measurement errors by 69% and minimizing internal test failures across critical quality checks.
  • Key contact for regulatory audits in 2023, ensuring compliance with ISO CPA standards and preventing potential $11 fines.
  • Rolled out a continuous improvement program based on Lean principles, leading to a 63% improvement in First Pass Yield (FPY).
  • Reduced scrap rates by 22% by identifying process inefficiencies and working with the production team to optimize workflow steps.
  • Monitored compliance with national and international specifications, sparking procedural updates that slashed downtime by 54% during quality check audits.
  • Achieved a cost saving of $4 annually by optimizing raw material inspection procedures, minimizing waste and rejecting substandard batches early.
  • Led a cross-departmental team to lower returns by 51% by refining labeling processes and ensuring product compliance with customer specifications.
  • Conducted comprehensive risk analysis on new production processes, mitigating quality risks and improving operational throughput by 20%.
  • Increased overall product quality metrics by 53% by introducing real-time quality monitoring dashboards, reducing response times to emergent quality control issues.

Affiliations

  • Mentor in procedure Quality Apprenticeship Program, guiding new recruits in the adoption of ISO standards and continuous improvement tools.
  • Completed Advanced Quality Management System Lead Auditor Training through Cedar Works, achieving mastery in compliance audits.
  • Holding certification in Supplier Quality Professional (SQP) through metric, focusing on resolving nonconforming material processes and lead-time reductions.
  • Association member with the Professional Society for Quality Assurance Professionals (PSQAP), engaged in continuous professional development.
  • Completed ISO 9001 Lead Auditor training from method in 2016, ensuring compliance in quality management systems.
  • Member of the European Organization for Quality (EOQ), involved in multi-national forums and workshops on global quality management systems.
  • Affiliate member in the Society of Manufacturing Engineers (SME), with specific interest in quality assurance and lean manufacturing.
  • Active participant in the Project Management Institute (PMI), incorporating project management best practices into quality oversight initiatives.
  • Recognized by the FDA Quality Consortium as a qualified participant in their pharmaceutical quality certification program 2017.
  • Completed training in quality auditing using HubSpot software, part of the company's initiative to digitize quality control procedures.

Certifications

  • Certified Pharmaceutical GMP Professional (CPGP) - ASQ
  • Medical Device Single Audit Program (MDSAP) Certification – method
  • Data Analysis for Quality Control Certification – process
  • Certified Quality Engineer (CQE) - American Society for Quality (ASQ)
  • Certified Professional in Supply Management (CPSM) – Institute for Supply Management
  • Good Manufacturing Practice (GMP) Compliance Certification – metric
  • Certified Quality Auditor (CQA) – American Society for Quality
  • Aerospace Quality Management Standard AS9100 Auditor Certification – method
  • Statistical Process Control (SPC) Certification – framework
  • Six Sigma Black Belt Certification – initiative

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