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Medical Devices Background

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Alvaro Viquez
Alvaro Viquez

Alvaro V鱈quez has experience in several quality engineering roles including transfers process development, production readiness reviews, and sustaining quality functions. His responsibilities involve preparing and approving transfer and validation protocols, conducting tooling and metrology validation, updating quality plans, and assessing process stability. He also leads quality teams, handles corrective actions, and serves as a subject matter expert for regulatory audits. Alvaro is skilled in statistical techniques such as measurement systems analysis, process capability analysis, design of experiments, and various t-tests and ANOVAs.

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Alvaro V鱈quezs QE profile background. 1. Transfers process 1.1 Involved in development of transfers strategies for both new products and similar products already running at the facility 1.1.1 Prepare/review/approve transfer and production validation protocols. Validate/Establish sample size, acceptance criteria, Risk Assessment Review i.e. FMEA in order to avoid discrepancies in core documents such as Protocols and Quality Plans. 1.1.2 Prepare appropriate protocols to execute MSA i.e. GRR e.g. Crossed or Nested ANOVA, Average & Range method, Attributes, OFFSET Studies. 1.1.3 Conduct tooling validation when required 1.1.4 Overseeing metrology department to make sure brand new or on hand equipment/fixtures fulfill process requirements. 2. Transition to Operation Support 2.1 Production Readiness Review PRR support and attendance as SME. 2.1.1 Update Quality Plans according with validation results. 2.1.2 Adjust AQLs levels for CTQs when required (NCRs Module) and IPs. 2.1.3 Assess process stability and control (SPC) to address Process Capability and Process Performance. 3. (Sustaining) Quality Engineering Functions encompassed: 3.1 CAPAs, NCRs, SCARs, ShipHolds generator, approver, designee 3.2 People Management: Quality Supervisor, Quality Technicians and Metrology*. 3.2.1 Incoming/Final release inspections ANSI/ASQ Z1.4, C=0, Certificates of Analysis/Compliance, Process Audits, FAIs and Tooling Qualification 4. Regulatory Affairs and Quality Assurance: 4.1 FDA, BSI and Customer Audits: SME for both Components and Final processes. 4.2 Oversight Review Board Report monthly generation/analysis/presentation. 5. Statistical test/techniques/tools frequently used: 5.1 RCA, MSA ANOVAs & Average and Range Method , SPC, t sample test, 2 sample t test, paired t test, DOE (Factorial 2^k), Homoscedasticity Test (variances), Capability Analysis, Tolerance Limits, Levenes test, Mood Median test, One way ANOVA, Two way ANOVA with Interaction.

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Medical Devices Background

  • 1. Alvaro V鱈quezs QE profile background. 1. Transfers process 1.1 Involved in development of transfers strategies for both new products and similar products already running at the facility 1.1.1 Prepare/review/approve transfer and production validation protocols. Validate/Establish sample size, acceptance criteria, Risk Assessment Review i.e. FMEA in order to avoid discrepancies in core documents such as Protocols and Quality Plans. 1.1.2 Prepare appropriate protocols to execute MSA i.e. GRR e.g. Crossed or Nested ANOVA, Average & Range method, Attributes, OFFSET Studies. 1.1.3 Conduct tooling validation when required 1.1.4 Overseeing metrology department to make sure brand new or on hand equipment/fixtures fulfill process requirements. 2. Transition to Operation Support 2.1 Production Readiness Review PRR support and attendance as SME. 2.1.1 Update Quality Plans according with validation results. 2.1.2 Adjust AQLs levels for CTQs when required (NCRs Module) and IPs. 2.1.3 Assess process stability and control (SPC) to address Process Capability and Process Performance. 3. (Sustaining) Quality Engineering Functions encompassed: 3.1 CAPAs, NCRs, SCARs, ShipHolds generator, approver, designee 3.2 People Management: Quality Supervisor, Quality Technicians and Metrology*. 3.2.1 Incoming/Final release inspections ANSI/ASQ Z1.4, C=0, Certificates of Analysis/Compliance, Process Audits, FAIs and Tooling Qualification 4. Regulatory Affairs and Quality Assurance: 4.1 FDA, BSI and Customer Audits: SME for both Components and Final processes. 4.2 Oversight Review Board Report monthly generation/analysis/presentation. 5. Statistical test/techniques/tools frequently used: 5.1 RCA, MSA ANOVAs & Average and Range Method , SPC, t sample test, 2 sample t test, paired t test, DOE (Factorial 2^k), Homoscedasticity Test (variances), Capability Analysis, Tolerance Limits, Levenes test, Mood Median test, One way ANOVA, Two way ANOVA with Interaction.