Bill W. Byrd
5617 W. 98th Terrace
Overland Park, KS. 66207
SKILLS/QUALIFICATIONS
Expertise in strategic planning, defining goals and team leadership tasks.
Strongly results-oriented with ability to coordinate multiple projects simultaneously with emphasis on obtaining full utilization of resources to achieve organizational goals and objectives.
Knowledgeable in documentation writing of Quality Procedures and Work Instructions (ISO).
In-depth strengths in multi-tasking and customer project improvement.
Provide in-depth product plan development with detailed test plan writing skills.
Demonstrated detailed project updating on a daily basis to upper management.
Expertise in Quality Error Tracking System software package control and maintenance.
Outstanding competence in communicating with engineering, and troubleshooting to resolve problems.
Skilled in working directly with people of all levels and diverse backgrounds and resolving issues in a successful manner.
Skilled in detail oriented ISO Internal Auditing of company Quality Standards to assure that all Quality Standards are being met to comply with ISO 13485, 9001 certification (obtained ISO 13485 Trained Auditor Certificate).
Self trained in basic Labview graphical software program writing.
AREAS OF EXPERTISE
Project Task Leadership Quality Documentation Writer
Proposal Development Input Engineering Troubleshooting
Certified ISO Auditor Quality Assurance
Quality Software Validation Project Performance Reporting
PROFESSIONAL EXPERIENCE
Software Validation Engineer and Quality Document Control
Pivot International, Lenexa, KS June 1998 – January 2009.
In-depth testing of embedded and application software tested within a PC and in a variety of products such as an endoscope medical device, treadmill monitors, digital image recognition devices, wireless communication devices, and other developmental software projects.
In-depth Electronic Assembly of products based from Assembly guidelines.
Complete control of software bug tracking, and other documentation to achieve product development milestones.
Basic Labview software program code writing to be used in software product testing.
Wrote detailed software validation test plans for all project product testing.
Worked very closely with the Engineering staff to troubleshoot issues that occurred in product development.
Proficient use of all aspects of Microsoft Office software.
Performed detail oriented ISO Internal Auditing of company Quality Standards to assure that all Quality Standards are being met to comply with ISO 13485, 9001 certification. Worked very closely with the Quality Manager at Pivot International as the lead auditor to help in the company gaining ISO 13485 Certification in October 2008.
Extensive experience working in a GMP regulated environment.
Extensive experience with document control databases.
Extensive experience with engineering change control.
Extensive document processing, document management, and associated, experience in a regulatory or clinical environment. Strong writing, quality review and editing skills.
Proficient in the review, formatting, analysis, proofing, and associated change process management of pharma and science documents to ensure that all documents meet the appropriate FDA and company procedures.
Electronic Test Technician
Technical Support (Phone Support to field technicians - 8/1997 – 6/1998)
Marley Pump Red Jacket Company Lenexa, KS November 1995 – June 1998.
Mechanical assembly, and detailed functional testing of Gas Station tank monitoring equipment.
Wrote detailed functional test plans for all of the tank monitoring equipment.
Received customer returned equipment that exhibited problems, tested to verify problem, and worked very closely with Engineering staff to help resolve the problem to achieve customer satisfaction.
Proficient use of all aspects of Microsoft Office software.
Performed detailed random Internal Quality Audits on manufacturing procedures to insure all Quality processes were being met to comply with ISO 9001 Standard for Manufacturing.
Promoted to Phone Technical Support August 1997 where I handled issues related to equipment startup problems, issues with equipment operation, and any technical support issues needing assistance.
EDUCATION
University of Cincinnati, Cincinnati, Ohio
Business Administration