Quality Engineer Document Control
Resume:
Veronica L. Williams
San Jose, CA 95127
Home: 408-***-**** Cell: 408-***-****
e-mail: **********@*****.***
CAREER Quality Management System Professional with over 28 years of experience developing,
SUMMARY implementing and maintaining medical device quality management systems to meet domestic and international regulatory requirements.
EDUCATION SAN JOSE STATE UNIVERSITY San Jose, CA
Bachelor of Science, Chemical Engineering
Minor: Computer Science
ASQ Certified Quality Engineer
ASQ Certified Quality Auditor
EXPERIENCE
11/09 – 08/22 MINERVA SURGICAL – Santa Clara, CA
Vice President of Quality Assurance
Responsible for developing, implementing, and maintaining a quality management system compliant with FDA QS Regulation, EN/ISO 13485, MDD, and Canadian Medical Devices Regulations. Responsibilities include CE Technical Documentation, Canadian Device Dossiers, Internal Audits; oversite of Document/Record Control, Non-Product Software Validation, Corrective Action/Preventive Action, Complaint Handling, Adverse Event, Field Corrective Action, and Product Release functions. Also serves as the Management Representative. Also responsible for External Audits including Medical Device Single Audit Program (MDSAP), Conformity Assessment under the MDD, and transitioning to compliance with the EU MDR.
05/02 – 10/09 SURGRX – Redwood City, CA [Now Ethicon Endo-Surgery, J&J]
Director of Quality Assurance
Responsible for developing, implementing, and maintaining a quality management system compliant with FDA QS Regulation, EN/ISO 13485, MDD, Canadian Medical Devices Regulations, Australian Medical Device Regulations, and Japanese Shonin Regulations. Responsibilities include auditing, validation (sterilization, shelf life, and packaging), biocompatibility, CE Mark Technical File and Canadian Medical Device Licenses new applications/amendments and product release. Also responsible for management of the Document Control and Incoming Quality Control Inspection, Product Complaint Handling functions. Created New Product Development Process that complies with FDA/ISO Design Controls.
05/97 – 05/02 NOVACEPT – Palo Alto, CA [Now Hologic]
Director of Quality Systems
Responsible for leading the effort in obtaining ISO 9001/EN 46001/CE Mark certification and FDA GMP Pre-approval Inspection clearance. Responsibilities include developing and implementing a comprehensive quality system encompassing internal/external audits, QSR/ISO 9001/EN 46001/CE Mark compliance, complaint handling, internal quality system assessment, quality training, product release, MRB, IDE and PMA support, corrective and preventive actions, design control process, biocompatibility, sterilization, and shelf-life validation. Direct experience in dealing with FDA Investigators in Pre-Approval inspections and responding to FDA observations. Also responsible for managing the Document Control and Inspection/Testing departments. Created New Product Development Process that compiles with FDA/ISO Design Controls.
V. Williams
07/96 – 05/97 CARDIMA - Fremont, CA
Senior Quality Assurance Engineer
Responsible for the development, improvement, implementation, and monitoring of quality systems to demonstrate the compliance to ISO 9001 and FDA requirements. Duties include ISO/cGMP internal audits; product release; MRB decisions; document review; standards and regulations tracking/maintenance; complaint investigations/analysis; acceptance sampling plan development; design control and statistical techniques implementation; quality information systems development. Refined existing New Product Development Process.
06/91 – 07/96 APPLIED IMMUNE SCIENCES - Santa Clara, CA [Now Sanofi-Aventis]
Quality Engineering Supervisor
Responsible for the development, implementation, and compliance of quality standards pertaining to raw material and product inspections; design control; supplier qualifications; calibration practices; internal audits; software and packaging validation; quality information systems; root-cause analysis. Duties included developing and monitoring budgets, hiring, training and evaluating department staff. Created New Product Development Process that complies with FDA/ISO Design Controls.
Quality Assurance Engineer
Responsible for the design, implementation, and management of quality assurance programs to confirm the conformance to specifications of materials, processes, and products. Duties included software and equipment validation; receiving, in process, and final inspections; batch record review; software/database development; and equipment calibration management.
11/87 – 05/91 UNITED TECHNOLOGIES, CSD San Jose, CA
Process Development Engineer
Responsible for implementing and directing the use of Statistical Process Control (SPC) in Manufacturing Operations. Duties included providing training to employees; conducting trend and defect analyses; assessing shop floor and non-manufacturing process performance through benchmarking; SPC consulting for other departments; liaise with subcontractors; giving presentations to management and DOD customers; handson processing in all stages of solid fuel rocket propellant production.
CONTRACT
POSITIONS
1986 - 1987
BIOTRACK INC. Mountain View, CA [Now Du Pont]
Quality Assurance Technician
Responsible for reliability testing on chemical reagent cartridges, blood controls samples, and electronic medical devices used to measure blood-clotting times.
ADVANCED CARDIOVASCULAR SYSTEMS INC. Mountain View, CA [Now Abbott]
Research and Development Technician
Responsible for fabricating and conducting Failure Analysis of balloon catheters used in treating coronary artery disease. Ran rupture and tensile test on catheters, performed statistical data reduction, and produced plastic components from injection molding.
STANFORD RESEARCH INSTITUTE INTERNATIONAL Menlo Park, CA
Associate Engineer
Responsible for operating and maintaining a chronic inhalation study. Set up, monitored, and troubleshot chemical apparatus and computers controlling the system. Ran particle size and permeation analyses.
V. Williams
PROFESSIONAL DEVELOPMENT
Acceptance Sampling
Human Factors for Medical Device Development
Canadian MD Regulations
Internal Auditing to MDSAP
CAPA and Root Cause Investigation
ISO 13485:2016 Quality Management Systems
CE Marking Medical Devices
ISO 14971 Medical Device Risk Management
Complaint Handling, Event Reporting, and Recall Management
Overview of Lean Manufacturing
Computer System Validation for Cloud and COT Applications
Packaging Validation
Concepts of Calibration and Metrology
Post-Market Surveillance Program Implementation
Dale Carnegie Course Effective Communications
Preparing and Submitting 510(k)’s, PMA’s, and IDE’s
Design Control Requirements and Industry Practice
Priority and Project Management
Design of Experiments
Process Validation
Design Verification & Validation
Process/Product Design Optimization
Developing and Validating Software for the MD Industry
RABQSA Certified ISO 9001/13485 Lead Auditor Training
Document Control & Records Management
Risk Management ISO 14971
Environmental Control & Monitoring
Software Verification and Validation
EU MDR 745/2017 Europe’s Medical Device Regulation
Statistical Process Control
Failure Mode and Effects Analysis
Statistical Techniques for Process Validation
FDA 21 CFR Part 11 Electronic Records
Sterilization Validation
MEMBERSHIPS
Association for the Advancement of Medical Instrumentation (AAMI)
American Society for Quality (ASQ)
Regulatory Affairs Professional Society (RAPS)
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