Quality Management - Document Control

Wendy M. Wilkey

*** **** **** *****. ******, NV *9436

C: 775-***-****

*********@*****.***

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Continuous success directing and achieving the development of advanced quality companywide to support aggressive business objectives.

20 years Supervisory – Management Experience

Background in First Article Reporting, PFMEA – Control Plans, GMP

Supply Chain Approval and Audit Management

Document Control and ECO Program Management

ISO and QMS Management

SOP development Management

CAPA and Continuous Improvement Management

Manage and execute a variety of projects simultaneously in order to achieve company goals, and meet customer demands and deadlines

Professional Experience

Selco Products – Reno NV 2011- 2020

Designs, manufactures and markets electronic controls, temperature sensors, thermal control devices, and related components for Telecommunications, Food Service, Electronic, Industrial and Medical Instrumentation, Aerospace Industry and the Military Government.

Quality Manager / Document Control / Compliance Officer Managed Company QMS, Supply Chain validation and approvals, Quality Production / Warehouse Improvements, Inspections, CAPA’s, KPI reviews, and cost reduction programs that consistently improved supplier and manufacturing product output, product quality and customer satisfaction.

Manage day to day quality-production crew outputs.

Supply Chain Project Management: Perform Supplier QMS Audit and sample evaluations for APSL approvals.

In conjunction with Manufacturing and Engineering Design Departments, conduct and verify internal-external PPAP-FAIRS, Process and Control plans, conduct First Articles for sample and first runs for New Production Introductions.

Document and Validate Configuration Management Process, Process flow and Procedures. Where appropriate, advise on changes and their implementation, and provide training, tools and techniques to enable others to achieve total quality.

Manage Document Information and ECO Change Control programs.

Reduced incoming, and final inspection defect rate 80% by developing a successful Quality program.

Responsible for Incoming, and Final Inspections of materials and assemblies.

Achieve monthly Companywide Quality KPI target goal of 98% or greater by working with Supply Chain, and Internal departments to continuously improve where needed to drive down error rates.

Manage Corrective Action, RMA’s, interact with Supplier and Customer base to resolve ongoing discrepancies

(8D’s, SCARS. Failure Analysis Reports, process –material improvements)

Auditor for Internal and External QMS Audits, and Material Inventory cycle counts. Prepare formal audit reports, and define audit schedule

Plan and direct quality compliance goals and objectives, and regulatory environmental requirements to ensure the set policies and goals are achieved.

Collect key process indicators (KPI’s) performance data for Management to evaluate/ improve operational processes and make necessary recommendations to appropriate departments as needed.

Facilitate Continuous Improvement Programs throughout all departments

Responsible for managing performance reviews, training, and disciplinary actions for personnel. Server Technology – Reno NV 2003-2011

Designer and manufacturer of remote power management equipment serving worldwide datacenter and telecom industries.

Quality Supervisor

Functional areas of accountability span corporate quality processes and key performance indicators, functional test control, supplier and management control, issue resolution, auditing, department budgeting, team leadership and development.

Responsible for managing all day-to-day operational activities for the inspection of assemblies, components and materials to ensure they meet all standards and specifications.

Interact with Shipping and Receiving departments to ensure incoming material inventory cycle count is accurate.

Use Key Process Indicators to evaluate/ improve operational processes and make necessary recommendations to appropriate departments.

Identify & segregate discrepant materials and report the root cause analysis findings to necessary areas.

Manage corrective/preventative actions, vendor scorecard, discrepant material databases and reports.

Assist with the onsite implementation of assembly and inspection methodologies for two Asian manufacturers.

Perform internal process audits to ensure QMS and procedures are in compliance. Additional work history available upon request

Educational Background & Credentials

Computer Science - Mission College - Santa Clara, CA

Internal Auditor – Certified Registrar Accreditation Board Quality System Auditor.

IPC/WHMA-A-620 Certified.

Microsoft: Certifications for Word, Excel, Access and PowerPoint

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