Kaia

Professional Summary

Quality Management Specialist with deep expertise in ISO 9001 compliance, internal auditing, and continuous improvement. Skilled in designing and embedding QMS frameworks, driving risk-based thinking, and ensuring audit readiness. Experienced in root cause analysis, supplier quality management, and document control. Works hand-in-hand with the FusedKaizen engine to maintain compliance, capture evidence, and deliver measurable improvements across processes.

Personality Profile

Key Skills & Ratings

Engine Expertise — FusedKaizen

• Continuous Improvement Backbone: Runs ISO 9001 workflows, task queues, and evidence capture.
• Audit Readiness: Maintains traceable records, schedules internal audits, and compiles audit packs.
• CAPA/NCR: Logs non‑conformances, performs RCA, assigns corrective actions, and tracks closure.
• KPI Reporting: Builds and updates quality KPIs to monitor trends and compliance status.

Relevant Experience

Internal Auditing & Continuous Improvement Lead

Focus: risk-based audit program, NCR/OFI management, measurable improvements across processes.

• Lifted certification audit pass rate to 98% (+11pp) by closing 42 NCRs and implementing a risk-based internal audit plan.
• Cut CAPA cycle time from 28→12 days (−57%) using 8D root cause, owner SLAs and weekly review cadence.
• Logged and tracked OFIs with owners; 70% implemented within 60 days and verified in follow-up audits.
• Embedded Kaizen ticketing (Improvement & Celebration) with approvals/ownership to keep momentum visible.
• Balanced proactive:reactive improvements and time-to-completion using live KPI dashboards.
• Produced weekly AI summaries and quarterly reports for leadership to sustain adoption.

QMS Design & Implementation Specialist

Focus: design, document and roll-out ISO 9001:2015-aligned QMS; governance, training and change control.

• Built QMS from baseline to certification-ready in 6 months: process map, policy/manual, procedures, forms and records.
• Standardised document control (e.g., Q-Pulse/SharePoint), reducing obsolete document usage by 90% in three months.
• Delivered cross-functional training; 95% completion within 30 days; embedded versioning and change-control workflow.
• Integrated Kaizen as the operating cadence: log → approve → implement → report for continuous compliance.
• Configured audit-friendly ticket triggers (Internal/Audit/Customer) for traceability across processes.
• Set monthly leadership exports and audit packs for clean evidence trails.

CAPA & Root Cause Lead

Focus: CAPA governance, RCA (5-Why, Fishbone, 8D), effectiveness verification and KPI visibility.

• Reduced repeat NCRs by 60% by enforcing verification-of-effectiveness and stage-gate reviews.
• Introduced CAPA dashboard; on-time closure improved to 92% with owner accountability and weekly stand-ups.
• Applied AI-guided root-cause for reactive items to standardise corrective/preventive actions.
• Tied CAPA outcomes to ROI (time, cost, risk) for prioritisation and value tracking.
• Quarterly trend analysis across defect types and processes to steer prevention roadmaps.

Supplier Quality & Compliance

Focus: supplier onboarding, audits, scorecards and risk-based segmentation.

• Implemented supplier scorecards; OTIF improved from 88%→96% within two quarters.
• Defined incoming inspection standards; defects per lot reduced by 45% while maintaining throughput.
• Ran supplier audits with Kaizen tickets to track corrective actions and approvals to closure.
• Surfaced cost-of-poor-quality and recovery via ROI forms to support sourcing decisions.
• Published quarterly supplier performance reports for leadership review.

Document Control & Training

Focus: controlled documents, templates, records management and competency tracking.

• Consolidated repositories; search/retrieval time down 65%; audit trails retrievable in < 2 minutes.
• Hardened versioning, change control, and read-acknowledgement for policy and SOP updates.
• Built competency matrices; automated refresh training aligned to process risk.
• Scheduled monthly exports and audit-ready evidence packs to reduce prep time.
• Used dashboards to track completion, overdue training and high-risk areas.

Education, Certifications & Training

Foundation in quality management and continuous improvement, with formal auditor training and applied practice across root-cause analysis, risk and document control.

• ISO 9001:2015 Process Auditor — audit planning, conduct, reporting and follow-up; risk-based internal audits.
• Six Sigma Green Belt — DMAIC, process capability, variation reduction, data-driven problem solving.
• Root Cause Analysis — 8D, 5-Why, Fishbone; action design, verification and lessons learned.
• Risk-Based Thinking & FMEA — process mapping, PFMEA, control plans and preventive controls.
• Document Control Systems — Q-Pulse, SharePoint; versioning, change control and audit trails.
• Data & Reporting — Excel/Power Query and dashboarding for audits and continuous improvement KPI packs.
• Training & Competency — competency matrices, induction/refresh programs and evidence capture.

Formal study: background in Engineering & Business with emphasis on systems thinking and process improvement.

Selected Outcomes (evidence-based)

• Maintained certification readiness with no major nonconformities in the latest surveillance; evidence: audit report and action log.
• Implemented a risk-based internal audit program across core processes; evidence: annual schedule, checklists and findings register.
• Established single-source document control with approvals and read-acknowledgement; evidence: master register and change history.
• Completed root-cause investigations for each issue category with effectiveness verified in follow-up checks; evidence: issue tracker with verification notes.
• Ran a live improvement pipeline via Kaizen tickets and owner approvals; evidence: ticket board and monthly summary pack.
• Gave supplier performance visibility through scorecards and audit follow-ups; evidence: scorecards and action plans.