Thomas Carroll Email & Phone Number

Pflugerville, Tx, Us

Austin, Texas Metropolitan Area

Now responsible for clients and assessors in North America, Central America and South America.

Austin, Texas Area

Responsible for regional

Austin, Texas Area

Rancho Santa Margarita, California

Lead Auditor of internal audits of the Applied Medical Quality Management System against ISO 13485:2016, ISO 14971:2007, 21CFR Part 820, MDD 93/42/EEC, and SOR/98-282 Lead Auditor of critical suppliers against ISO 9001 and ISO 13485 QMS standards Schedule Internal Audits based on Compliance Risk Assessment, Standards and Regulations Identify audit findings as conforming, nonconforming or needs improvement and assign Corrective and Preventive Action Requests as necessary Perform follow-up verification activities of implemented action items for completeness Work closely with Quality Systems, Regulatory Affairs, Engineering, Procurement, Branding, Clinical Development, Manufacturing and Distribution Centers Audit variety of internal manufacturing processes such as injection molding, insert molding, pad printing, punching, extrusion, demolting, machine shop, tumbling and passivation, sub-assembly, clean room assembly, E-beam sterilization, warehouse, kitting, and distribution. Audit Systemic processes such as Document Control, Design and Development Controls, Process Validation [IQ/OQ/PQ/PPQ], Work Surface Bioburden and Product Bioburden. Audit manufacturing locations in the US and Netherlands, and sub-process manufacturing locations in Rancho Santa Margarita, and distribution centers in US and international

Houston, Texas Area

As Segment Quality Champion [Dec 2012 - July 2016]:Updated BDT Segment Quality Management System (QMS) standards to meet changes in requirements in ISO 9001:2015 (QMS) and API SPEC Q1, compliant with requirements in API SPEC Q2 and Corporate Schlumberger Policies and QHSE Objectives. Developed QMS procedural templates that were successfully implemented at BDT Segment Machine Shops and Service Centers requiring QMS ISO 9001 and API SPEC Q1 certification domestically and internationally. Performed +10 Full QMS internal audits Domestically and 2 Full QMS internal audits Internationally at BDT Segment Service Centers and Machine Shops [each lasting 3-5 days] Developed and released BDT Segment QMS audit checklists covering all QMS Elements Lead supplier audits at critical suppliers for Fishing & Remedial equipment in Houston Functioned as BDT Segment QMS Subject Matter Expert Consulted on Risk Assessments for processes critical to product quality and quality delivery.As Segment Asset Management Project Manager [Feb 2015 - July 2016]:Led Material Traceability Project between BDT Manufacturing and 6 Tier-1 BDT locations – linked material certifications from old manufacturing system to new field management system Led Idle Asset Program in +40 countries on 6 continents – managed tools added to program and approved redeployment and requests to use in host country HQ Lead for tool and accessory redeployment for Fishing & Remedial bases in Russia and Venezuela – facilitated redeployment from countries with excess tools and accessories

Foothill Ranch, Ca

Direct reports of a Quality Control Supervisor and 4 technicians, 3 QC Leads, 12 Process Auditors and +60 QC Auditors Led process improvement projects to reduce internal scrap – increased yields by 30% Led streamlining Kaizen lean manufacturing activities using cellular manufacturing work cells on assembly lines; 20% increase in volume; Led Oakley’s turnaround from being parent company Luxottica’s lowest performing supplier in 2011 to Top-in-Class in 2012; from outgoing quality level >15K PPM to < ~3K PPM in 2012 Monitored manufacturing KPI’s; daily yields by assembly line; failure mode Pareto, scrap dollar value, and monitor trends Developed and oversaw QC Auditor Attribute GR&R and training program – increased overall team compliance with internal requirements from ~95% to ~98% Approved corrective action and preventative action (CAPA) by QC Technicians and Leads Created synergetic relationships with process, manufacturing and design engineering Led MRB meetings in reviewing nonconforming product reports (NCMR) Supervised Calibration of production equipment through use of outside calibration labs Led Variable GR&R studies on measurement and monitoring equipment used in production Monitored efficiency of injection molding, painting, plasma cleaning, cutting/routing, and lens coating processes

Irvine, Ca

Helped maintain ISO 9001, QS 9000 (automotive), AS 9000 (aerospace) certifications Continued job growth, started as Quality Data Analyst, to Quality Engineer for flexible circuits then eventually concurrently the Quality Engineer for fiber optics for military customers Facilitated transfer of military fiber optic program to Tijuana, Mexico between 2004 and 2005 Led continuous improvement activities using DMAIC principles and DOE’s Led variable GR&R studies on measurement and monitoring equipment used in production Acted as main contact for customer complaints – led CAPA investigations which included visiting customer locations to identify root causes. Quality representative during Production FMEA and Design FMEA exercises Monitored manufacturing process control charts and calculated First Time Quality (FTQ) daily with Process Engineering – including metal plating, chemical wet process, lamination, routing and stamping dies, visual coordinate measuring machines, and AOI machines

Certificate, Regulatory Affairs And Compliance

Bachelor'S Degree, Political Science And Government

Associate'S Degree, Business Administration And Management, General

Project Management