1. Alvaro Víquez’s 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, Levene’s test, Mood Median test, One way ANOVA, Two
way ANOVA with Interaction.