Johnson & Johnson Professional, Inc.
Sr. Clinical Research Associate
1994-1999
1994-1999Codman and Shurtleff (Johnson & Johnson)
Sr. Regulatory/Clincial Affairs/Biostatistician1991-1994
1991-1994Sr. Quality Engineer 1989-1991
1989-1991•Wrote 510ks, interfaced with FDA, participated in all aspects of clinical study management
Wrote 510ks, interfaced with FDA, participated in all aspects of clinical study management•Evaluated engineering changes with approval authority; determined whether a 510k was needed
Evaluated engineering changes with approval authority; determined whether a 510k was needed•Statistical Quality Assurance including statistical process controls for injection molding
Statistical Quality Assurance including statistical process controls for injection molding•Wrote guidance documents for upper management on reimbursement, software validation, and pre-producation quality assurance
Wrote guidance documents for upper management on reimbursement, software validation, and pre-producation quality assurance•Developed a process control system that identified improperly milled silicone elastomer, saving money and possibly preventing a recall
Developed a process control system that identified improperly milled silicone elastomer, saving money and possibly preventing a recall•Supported the Bactiseal shunt (a combination drug-device) in the following capacities; protocol development, database design and creation, site initiation, site initiation, site monitoring, investigational device inventory management including distribution and accounting, FDA interface and reporting
Supported the Bactiseal shunt (a combination drug-device) in the following capacities; protocol development, database design and creation, site initiation, site initiation, site monitoring, investigational device inventory management including distribution and accounting, FDA interface and reportingSikorsky Aircraft, United Technologies (Aerospace)
Quality Systems Engineer/Statistician 1987-1988
1987-1988• Process Validation; Statistical QA & SPC (machining, plating). Initiated a machine tool capability study, saving $450,000.00; created division-wide policies and procedures
Process Validation; Statistical QA & SPC (machining, plating). Initiated a machine tool capability study, saving $450,000.00; created division-wide policies and procedures• Wrote a statistical report in connection with a multi-billion dollar recall
Wrote a statistical report in connection with a multi-billion dollar recallGeorge W. Moore, Inc (High Volume Machined Products)
Quality Control Manager 1986-1987
1986-1987•Saved #1 account by controlling critical dimension with an innovative use of SPC; responsible for customer correspondence, MRB, and supervising set-up and production inspectors
Saved #1 account by controlling critical dimension with an innovative use of SPC; responsible for customer correspondence, MRB, and supervising set-up and production inspectorsCambridge Machined Products (Medical Device Components)
Quality Department Manager 1985
1985•Responsible for all aspects of quality assurance. Supervised seven inspectors. Audited suppliers and interfaced with medical component and automotive component customers
Responsible for all aspects of quality assurance. Supervised seven inspectors. Audited suppliers and interfaced with medical component and automotive component customersAmerican Research Partners
Copyright © 2020 American Research Partners LLC
All Rights Reserved.
Designed, conducted and analyzed the results of a clinical trial for an image-guided surgical navigation system for neurosurgery. This included writing the protocol (and developing the measurement system for assessing system accuracy), designing the database (in Access), analyzing the results in SAS, writing all statistical reports for submission to the FDA, monitoring the study, and controlling the inventory of investigational devices. The product was approved for commercial distribution sooner than expcted
.
Provided technical support to neurosurgeons and R & D professionals for peer reviewed publications in neurosurgery and othopaedics
Supported a combination Drug/Device (Monitoring, statistical analysis, reports to FDA, created clinical databases in Medlog and Access, managed clinical inventory)
Supported QA and R & D with respect to experimental design and statistical analysis
.
.
.
.
Carleton Southworth: Curriculum Vitae
Continued on page
