Quality Engineer Document Control
Resume:
David W. Elliott
******@*******.***
Summary of Qualifications:
Hands-on team player, a seasoned professional in Quality Engineering with over ten years experience in the biomedical and medical device industries with demonstrated competencies in the following areas:
FDA 21CFR Parts 11, 820 and 111, ISO 13485, MDSAP and ISO 14971 Medical Device Standards and cGXP requirements pertaining to medical devices and IVD laboratory developed tests.
CAPA administration and investigation, specializing in motivating cross-functional teams and integrating risk analysis into the CAPA process.
Six-sigma Green Belt for voice of the customer project for a global medical device CAPA system.
Product Return process improvements.
Design control support to improve the upstream development process.
Verification and validation efforts.
Document and records management: including development of internal EDMS tools, use of online electronic document management platforms VeevaVault and Agatha; control of external standards, etc.
MRB and yield improvement projects.
QSR/GMP training, conducted dynamic and engaging courses.
Exceptional Microsoft Office skills with outstanding report tool innovations.
Quality team management
Audit support and leadership
Employment History
02/22 – 09/22 Document Control Manager, InCarda Therapeutics, Inc.
Managing Document Control and Training activities.
Processing and archiving GXP records.
Support Regulatory submissions and on-going compliance in support of product development.
12/20 – 02/22 CAPA Analyst (contract), Abbott
Performing CAPA investigations for diagnostic instruments (hematology).
Contributing to risk management and design controls in a closed loop system.
Extensive use of TrackWise and Serena Business Management software for tracking defects.
01/18 – 09/20 Principal Equipment Specialist, Roche.
Performing product release with cross-functional team coordination.
Demonstrated engineering and validation expertise for move to new laboratory at Santa Clara site.
Put people first attitude. Spearheaded cultural changes in operations quality.
Document creation and approvals (IQ, OQ, PQ, SOP etc.)
Developed Excel spreadsheet and macro validation process.
Maintained record management system for electronic and hardcopy documents.
Quality system development of facilities environmental monitoring.
Quality System Training and mentoring for staff.
Support for audits and implementation of MDSAP and ISO13485.
05/17 – 12/17 Document Migration Project Mgr, Roche.
Championed document migration of 2500 active documents from one electronic system another.
Developed automated tools (Excel VBA) to optimize the process.
Forged relations between EDMS software analysts and local QA requirements.
Engaged participants in dynamic training sessions.
Won “Own It” achievement award for accomplishments associated with the migration project.
10/15 – 02/17 Document Control Manager, Natera Inc.
Performed document change order approvals for QA.
Maintained Veeva document system admin configuration.
Training and mentoring for staff.
Support for audits and ISO13485 implementation.
10/14 – 10/15 Document Control Specialist, Natera Inc.
Demonstrated excellence in document control management using Veeva QualityDocs EDMS.
Extension into design, configuration and liaison with Veeva Systems.
Outstanding document support services for quality system compliance across multiple departments.
Leadership in quality assurance to meet aggressive project goals and foster continuous improvement.
03/14 – 10/14 Quality Consultant, Self Employed
Providing professional quality engineering services for the nutraceutical and medical device industries.
Developing and executing equipment qualification projects (IQ/OQ/PQ).
Pioneering instrumental data gathering techniques to inform crucial quality metrics.
Demonstrating skills in presenting key information to executives and managers.
Coordinating cross-functional teams to define quality requirements.
Building software tools for managing quality data.
08/13 – 03/14 Quality Engineer, CellScape Corporation
Spearheaded software systems in Excel for managing crucial laboratory data.
Led project team to implement the semantic, web-based Syapse application.
Managed a quality technician to support operations and development.
Programming in Visual Basic for Applications and Python scripting.
Quality engineering support for state-of-the-art cell biology imaging laboratory.
02/13 – 03/14 Doc Control Specialist, CellScape Corporation
Streamlined and enhanced the Document Control Process through system improvements.
Developed automated Doc Control tools using VBA (Microsoft Office) tools.
Accurately managed document changes and releases in a timely fashion.
Coordinated and tracked employee training on quality documents.
Provided MSDS system management.
Managed external standards.
01/06 – 02/13 Engineer and Psychotherapist, Client Voice Innovations
Providing engineering and counseling services for behavioral health agencies.
Working with customers and managers to specify software requirements for automated tools.
Developing a groundbreaking data management and reporting application (ASIST for Agencies) to
track effectiveness of psychotherapy.
Accomplished Microsoft Office programmer using Visual Basic for Applications
(VBA), specializing in Excel and Access (with SQL).
Conducted dynamic and engaging training and support services for managers and staff.
Provided professional psychotherapy for groups and individuals.
1/99 – 01/06 Sr. Quality Assurance Engineer, St Jude Medical CRMD
Served as manager of the Corrective and Preventive Action CAPA system.
Led project teams in field return investigations and risk management projects.
Conducted critical component and process validation activities.
Provided crucial design assurance support.
Developed automated report writing tools to support the product returns group.
Conducted employee training for ISO and FDA QSRs.
02/96 – 12/98 Manufacturing Test Quality Engineer, Ventritex
Support and development of medical device processes and products.
Supported manufacturing to resolve production line issues impacting product yields.
Performed product failure investigations and established data collection systems to feedback manufacturing or design issues to engineering.
Improved documentation techniques for product inspection.
Conducted process analysis and employee training for ESD product handling.
Experience with precision electrical and mechanical measurement and analysis – oscilloscopes, micrometers, calipers, depth gauges etc.
01/94 – 02/96 Electrical Engineer / Manager, Psychophysics Laboratories
Responsible for research and development of new products.
Supervised 3 assemblers and 1 inspector.
Optimized manufacturing and inspection techniques.
Developed test procedures and quality assurance policies.
Provided excellent and timely technical support with customers for troubleshooting and repair.
Education
Bachelors of Science, Electrical Engineering, West Virginia University
Masters of Arts, Psychology, John F. Kennedy University
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