Troy E. Email & Phone Number

Austin, Texas Area

• Responsible for all aspects of cGMP and regulatory quality requirements for external customers in FDA-regulated industries
• Perform compliance assessments to 21 CFR 700 and 21CFR110/111
• Responding to and perform remediations for FDA 483s and Warning Letters that have resulted from inadequate QMS.
• Perform full spectrum auditing of GMP, GCP, and GLP suppliers
• Lead risk assessment sessions using a variety of tools
• Develop risk assessment/risk management procedures

Austin, Texas Area

• Direct all aspects of the corporation’s QMS and regulatory quality requirements focused on building customer trust.
• Developed and implemented a risk-based QMS to ensure conformity to requirements that support the business resulting in becoming State of Texas certified manufacturer.
• Performed supplier qualification audits to ensure the quality of incoming materials and supplier performance.
• Managed the monitoring, measurement, and review of internal processes, and perform internal audits as required.
• Reported to executive management on the performance of the QMS (e.g., results of quality audits, corrective actions), including all business process improvements.
• Established corporate governance system to drive weekly, monthly, quarterly and annual quality communications.

Austin, Texas Area

• Directed a multi-site quality management system centralized on driving overall customer trust and satisfaction.
• Created/launched framework programs designed to maximize corporate strategic quality and operational excellence, formulate key strategic quality objectives to optimize sustainable business processes, and oversee.
• Cultivated and foster trusting relations with customers to accelerate overall market share growth.
• Spearheaded all internal and external auditing procedures (ISO 9001:2015, ISO 13485 and 21CFR standards) that consistently result in exceptionally high customer ratings, and meeting all regulatory requirements.
• Lead project teams with a structured and consistent approach through utilizing strategic maps and balanced scorecards, effectively slashing forecasted costs and improving levels of quality/delivery.
• Directed a diverse range of multiple program teams (quality engineering, inspection, supplier development) as well as 8D teams that implemented effective RCCA/CAPA, resulting in zero repeat discrepancies.

• Directed operations for a 300-member aviation operations and logistics team, providing time-sensitive security services to multiple stakeholders in geographically dispersed regions.
• Led a 125-member multi-functional team providing aviation technical and logistical services supporting global stakeholders; rated as the best of 8 peers by the Brigade Commander with commendable Department of Defense.
• Enhanced collaborative partnerships with cross functional U.S Army units.
• Implemented new business processes to gain efficiencies that reduced U.S. Government operations and maintenance costs by leveraging Army resources.
• Launched national-level safety/behavioral health campaigns, championing initiatives for the U.S. Army.
• Presented the unit's 'Outstanding Leadership' award as COO for a 75-person flight operations and logistics team, managing multi-million dollar training and maintenance programs.

Austin, Texas Area

• Oversaw development, implementation, and coordination of product quality assurance programs within a high-volume start-up manufacturing environment. Directed implementation of QMS, CIP programs, and quality.
• Collaborated with senior management in the development/standardization of new company-wide policies, operating procedures, and objectives. Implemented strategies designed to slash costs, improve quality, and optimize.
• Coordinated with engineering department to evaluate manufacturability in correspondence to quality assurance for new product design. Implemented quality improvement initiatives centralized on eliminating defects in new.
• Continually recruited exceedingly qualified personnel to maintain a high-performance workforce. Formulated comprehensive training curriculum for quality engineers/inspectors centralized on process improvement.
• Utilized specialized tools and techniques to continually regulate customer satisfaction levels. Performed a broad range of company-wide assessments focused on training, research, planning, policy, and program evaluation.

Austin, Texas Area

• Directly responsible for the development and implementation of the quality assurance program, and established product quality guidelines, process development, training, establishing and enforcing quality standards and.
• Established quality and reliability standards by studying product and consumer requirements with other members of management and with production operators, technicians, and engineers.
• Established in-process product inspection standards by studying manufacturing methods; devising testing methods and procedures.
• Achieved financial objectives by preparing the quality assurance budget; scheduling expenditures; analyzing variances; initiating corrective actions.
• Contributes to team effort by accomplishing related results as needed.

Austin, Texas Area

• Provided comprehensive consultation for business process improvement services.
• Monitored/reported customer satisfaction levels, executed a diverse range of assessments (training, research, planning, policy, program), and governed program compliance with standardized policies and procedures.
• Finalized and delivered detailed administrative/performance reports to executive team.

Austin, Texas Area

• Ensured that quality activities and manufacturing records are in compliance with SOPs, regulatory requirements and ISO:13485and FDA standards; determined the need for corrective actions, ensured proper documentation.
• Advised other management team members and staff regarding daily quality assurance/quality control issues affecting sampling suitability, product quality, product release and shipment and resolution of same; develops.
• Lead facility employee training plans and modules in accordance with regulatory requirements.
• Trained laboratory and plasma warehouse staff on Quality and cGMP procedures.
• Wrote and reviewed laboratory and plasma warehouse SOPs for implementation.
• Performed final QA review and release of test results to ensure results meet regulatory specifications.

Bachelor Of Science - Bs, Education, Training And Development

Activities and Societies: R.O.T.C., Tau Kappa Epsilon International Fraternity, Student Government Senator, United Way Campaign Chairman.

M.S., Quality Systems Management

Activities and Societies: Student project and class leader.The National Graduate School of Quality Management (NGS) is an accredited.