Veronica L. Williams

**** ******* *****

San Jose, CA 95127

Home: 408-***-**** Cell: 408-***-****

e-mail: adte5z@r.postjobfree.com

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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