Tom Persons Email & Phone Number

Gainesville, Fl, Us

Amsterdam, Noord-Holland, Nl

Sr Quality Engineer for New Products. Establish and monitor Design Controls for new and sustaining MRI imaging coils and image software Assist in complaint investigations and quality system updates. Site Risk management Subject Matter Expert Maintain Product Risk Management processes and risk files

Milwaukee, Wi, Us

member ASQ HACCP since 2013

Leading provider of home respiratory care devicesSr. Design Quality Engineer- Establish and monitor Design Controls on new and sustaining products. Develop and maintain risk management files (ISO14971) for new and released products. Review and approve product change notices, design development plans, design reviews, and V&V reports. Update and maintain Quality System documents (Standard Operating Procedures-SOP).- Created and released Product Deviation process (SOP), included the training of personnel at 4 Respironics facilities- Integrated Key Safety Component Listings into the Risk Management and Manufacturing SOP’s - Created Key Components Listings for Legacy Products to close gaps in risk management system- Provide Sustaining design quality support on Trilogy, Respironics flagship ventilator product. - Product Risk Manager for Trilogy , Vision, and Cough Assist ventilator products- Train personnel on new and revised SOP’s- Compliance Engineer, Compliance Testing Lab.(2 months)- Internal Auditor

Deerfield, Illinois, Us

Responsible for establishing and monitoring Design Controls on new dialysis productdevelopment and legacy related projects. Responsibilities includes: review and approval of Functional, Systems, and HardwareRequirements; review and approval of verification and validation test plans and reports;Active participant in Design reviews and approval of final design review reports; verifycompliance to GDP, Baxter design processes and FDA QSR design control requirements. Create Quality Plans and Reports for various product improvement projects.Create Risk Management Plans and Reports for product improvement projects.Create and maintain Standard Operating Procedures (SOP's) for Calibrated EquipmentManagement and Facility Controls.- QE representative on the HomeChoice(peritoneal dialysis) and Arena (hemodialysis)Legacy projects. Maintained DHF's for various product improvement projects.Provided QA support on product support projects and CAPA items as needed.Baxter Certified Regulatory Affairs Designee (performed first tier Regulatory reviews ofchange proposals).Responsible for monitoring ESD compliance and equipment calibration issues at R&Dfacility.

Responsible for performing failure analysis work on customer returned products. Jobrequired interfacing with design engineers, quality engineers, regulatory affairs, andupper management. Over see and reviewed the work of four techs.Created and reviewed failure analysis reports on returned products.Establish improved failure analysis procedures and documentation of test methods. Perform root cause analysis for failures.Wrote and developed lab test procedures.Participated in various continuous improvement teams, 5S and Kaizen events.Member of the Service and Repair team to implement and test an improved repair andcomplaint reporting system.

Responsible for establishing quality systems for new electrical-mechanical surgicalproducts.Developed quality plans for new products and receiving inspection test procedures.Help R&D Engineering follow QSR Design ControlsDeveloped and wrote process validations and test verifications for new manufacturing andtesting processes (IQ OQ and PQ).Created final inspection tests for new products.Audited new suppliers for compliance to design requirements.Identified and corrected internal audit corrective actions in the product service/repairand manufacturing floor.

Lake Jackson, Tx, Us

Initiated a training class to provide vendor and supplier managementto small local businesses.

Performed Product Quailifications -Pacermakers and pacing leadsResponsible for the design verification of endocardial pacingleads and pacemaker headers. Qualified over 80 new products, by developing test plans, FMEA's, accelerated life tests,product qualification tests, and product evaluation tests. In addition authored finalqualification reports which are submitted to the FDA for approval.Corresponded with the FDA regarding qualification reports and real time submissions. Assisted the in manufacturing process development, through process verification andvalidation testing.Reliability Assurance sign off authority on drawings, engineering change notices, andMRB's concerning leads and pacemaker headers. Supervised the work of three lab technicians, by matching individual technician's skilland availability to the assigned task.Established workload requirements and budget for leads related projects. Established and implemented documentation of basic reliability requirement guidelines forpacing leads and headers, test reports, and test procedures. Provided feedback to company representatives in Europe concerning the AIMD test standards(CENELEC) and recommending changes to the standards. Corresponded both written and orally with design engineering, and manufacturing personnel

Dallas, Tx, Us

Material Team Engineer (Procurement Engineer) on the HARM and a TI proprietary program. Responsible for the following components: gyroscopes; roll motor/tachometers; liftactuators; potentiometers; pressure transducers: gas bottles; gas lines; bearings;athermalization bellows. Corresponded both written and orally with design and manufacturing personnel both insideand outside TI. Created and developed specifications for critical missile and flight control componentsand subsystems.Selection and development of suppliers.Performed technical review of vendor design proposals, changes, test procedures, testreports, and failure analysis reports. Assisted in failure analysis of components and established resulting corrective actions. Assisted in contract negotiations by providing cost estimates and design/fabricationschedules. Trained Source Inspectors on the critical aspects of various purchased components.

Dallas, Tx, Us

Design Engineer for the HARM program. Provided mechanical design and production supportfor the HARM Flight Control Section.Designed metal fabricated parts; packaged electronics (PWB's, and flexible circuitcables).Developed and performed environmental testing.Created and submitted test reports to management and the customer (Navy).Created and submitted Engineering Change Proposals (ECP) to the Navy.Prepared cost, schedule and labor estimates to implement design changes and testprograms.Corresponded both written and orally with manufacturing, and Navy personnel.