Keith Yanase Email & Phone Number

San Diego, CA, US

San Diego, California, US

• I joined Dexcom as a Sr. QA Engineer during the height of the pandemic. My role is primarily centered around Quality Systems data integration and visualization at various levels of the organization to accelerate the.
• Procured Microsoft's Power BI Premium capacity for the Quality organization.
• Identified Quality KPIs for daily, weekly, monthly, and quarterly reports.
• Developed over a dozen automated reports and dashboards contributing to a significant reduction in engineering labor costs.
• Enabled a 75% reduction in nonconformance investigation backlog by developing and validating a Power BI report for calculating risk and occurrence rates.
• Encouraged a cultural shift and adoption of automated data analytics to monitor the health of the Quality System.

Carlsbad, California, US

• I was promoted to a Quality Engineer after working here for just over a year. I continued to managed the complaint system and validation program while also taking the lead on the supplier quality program and product.
• Qualified Foxconn Medical as a manufacturer of finished goods. Led the on-site audit to evaluate the QMS for effectiveness and compliance.
• Created a Power BI Cost of Quality dashboard and identified various cost reduction opportunities.
• Developed a Kaplan-Meier curve to track product survivability in the field and justified the reduction of the product warranty period by 1 year.
• Validated the Supplier, Complaint, and RMA modules of an electronic QMS system and integrated it with Salesforce CRM.
• Drove the Quality deliverables and implemented a customer-facing web-portal for complaint management, asset management, and RMA handling.

Carlsbad, California, US

• I was hired as Validation Engineer but also heavily involved in various other QA functions including CAPA, NCP, Complaints and Product Returns. Developed and executed validation protocols (IQ, OQ, PQ, PV), analyzed.
• Reduced annual operating cost by >$1.0M by completing validations of numerous manufacturing equipment, software, and processes.
• Developed and implemented a plan to restructure the complaint process to optimize tracking, trending, and reporting capabilities.
• Drove down the average time for complaint investigations by >85% within the first few months of employment.

San Diego, CA, US

• The M&A between Abbott and Alere resulted in my move to Quidel. I performed product complaint investigations and escalated failure investigations. I was selected and trained to serve as a level I internal auditor where.
• Reduced on-boarding time of new team members by >70% by developing comprehensive training materials and technical documentation.

North Chicago, Illinois, US

• As a product complaint investigator, I spent roughly 60% of my time in the office and 40% in the lab. Failure analyses were performed using returned and retained products and/or samples.Within the first three months I.
• Achieved >60% reduction in complaint investigation backlog by streamlining the investigation process.
• Managed the inventory of >1,000 retention lots and optimized the product retention process.
• Enhanced the biweekly complaints meeting agenda and standardized the reports presented.

North Chicago, Illinois, US

• My humble beginnings. I was hired as a contractor to support the increase in customer call volume due to an unforeseen product deficiency. It was a call center job where I documented customer inquiries and.
• Ensured the timely completion of a field corrective action by streamlining the workflow for the response team.
• Identified and investigated a flaw in the customer mailing system and prevented the unnecessary distribution of >$100,000 worth of letters.

Master Of Science - Ms, Pharmaceutical Sciences

Certificate, In Vitro Diagnostics

Bachelor Of Arts - Ba, Biology/Biological Sciences, General