Johnson & Johnson Professional, Inc.

Sr. Clinical Research Associate1994-1999

Codman and Shurtleff (Johnson & Johnson)

Sr. Regulatory/Clincial Affairs/Biostatistician1991-1994
Sr. Quality Engineer            1989-1991

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

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

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

Sikorsky Aircraft, United Technologies (Aerospace) 

Quality Systems Engineer/Statistician 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

Wrote a statistical report in connection with a multi-billion dollar recall

George W. Moore, Inc (High Volume Machined Products)

Quality Control Manager      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

Cambridge Machined Products (Medical Device Components)

Quality Department Manager       1985

Responsible for all aspects of quality assurance. Supervised seven inspectors. Audited suppliers          and interfaced with medical component and automotive component customers

American  Research Partners
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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

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