KENNETH ENSELL 9323 Manchaca Road, #1217 * Austin, Texas 78748 * ke114f61e@westpost.

net Home: (512) 280-6375 * Cellular: (727) 466-7033 QUALITY ASSURANCE SUPERVISOR ~ Expertise Developing & Implementing Effective QA Systems that Deliver High-Qua lity Work On Time & On Budget. ~ Award-winning professional with 15+ years of Quality and Regulatory Experience a nd a history of success achieving objectives and ensuring compliance with domest ic and international laws, standards, and regulations. Passionate about safety, quality, and accomplishing tasks correctly the first ti me. Equally able to lead a team, work as part of a team, and work independently. Known for going above and beyond the call of duty and for proven ability to ini tiate and implement policies, procedures, and processes that consistently meet o r exceed requirements. Exceptional communication, presentation, writing, editing , organizational, and research/investigative skills, with superior attention to detail. Noteworthy skills and experience auditing plants and factories to ensure complia nce with customer requirements and internal policies and procedures; training pe ople; setting up calibration systems and programs that ensure accuracy to NTBS s tandards; establishing document control and record retention systems; and implem enting ECO/ECN. Software Proficiencies: Word, Excel, Outlook, PowerPoint, Project, Visio, TrackW ise, and MetaPhase. System Proficiencies: Oracle, SAP understanding, Citrix. KEY QUALITY COMPETENCIES * CAPA System * Adverse Event Reporting * Quality System / ISO * Internal Audits * Regulatory Compliance * Quality Reporting * Quality Assurance * Certification * Quality Training CAREER CHRONOLOGY Baxter Healthcare, Tampa, Florida 3 Years Supervisor, Document Control, Record Retention & Disaster Recovery (2 Years) Promoted at medical device manufacturing company to lead a staff of 5 and overse e the set-up of a document control system for the R&D group that would allow eas y access for the engineering group. Determined the type of equipment and the loc ation. Structured the document control and retrieval mechanisms. Coordinated ext ensively with the Chicago office to secure documents stored there. Conducted tra ining classes. * Recognized for improving efficiency and reducing redundancy. * Improved access to documents and automated the document retrieval process. * Reduced by 50% the time required to transfer documents. * Created an online repository and the first-ever disaster proof room that ensur ed the safety of thousands of documents in order to meet FDA requirements for a 510(k) submission. CAPA Investigator / Technical Writer (1 Year) Originally hired as a subject matter expert to investigate and resolve CAPAs in response to an FDA warning letter. Wrote and secured approval for corrective act ions. Managed a staff of 20 lab technicians. Conducted internal audits to ensure procedural compliance. Oversaw the calibration process for the hemodialysis mac hines and managed the budget for purchasing calibration equipment. Determined th e feasibility of corrective actions designed to improve customer satisfaction. * Played a key role in keeping the company in operation by getting the FDA to wi thdraw warning letter. * Significantly reduced complaints and improved customer satisfaction by initiat

ing a process to receive customer feedback. * Helped management understand problems occurring in the field and how to correc t those problems; worked closely with the manager to write FCAs (Field Correctiv e Actions) and developed technical bulletins for manufacturing staff to address FCAs. * Reduced SME involvement in CAPAs 20% by volunteering to develop documents for the engineers and obtain their approval. Wrote 8 complex, detail-oriented CAPAs, creating procedures and flow charts relevant to the CAPAs. ...CONTINUED... KENNETH ENSELL H: (512) 280-6375 * C: (727) 466-7033 Kinetic Concepts, San Antonio, Texas 2 Years CAPA Specialist / Technical Writer Recruited as a CAPA Specialist to support sustaining engineering in documenting process improvements and responses to CAPAs. Following an FDA audit, challenged to transition to a role investigating and resolving quality issues. * Resolved quality issues and played a key role in company passing all ISO and F DA audits by identifying the root cause of the quality problem, reviewing correc tive actions, and then writing Standard Operating Procedures (SOP) to address th e problem. * Decreased equipment assembly time 25% by mapping and writing 12 sets of assemb ly-line instructions. * For less than $500 and in less than 6 days, resolved a safety violation and av erted a potential lawsuit by identifying the problem prone to causing explosions and initiating the installation of Electronic Static Discharge (ESD) equipment. * Contributed to a zero-accident safety record by working closely with OSHA to e stablish Material Support Data (MSD), relocating equipment, installing 6 eyewash ers, making safety documents accessible, and establishing processes for safely s ecuring chemicals. Takata Seatbelts, San Antonio, Texas 2 Years Quality Systems Manager Hired to audit and ensure that automotive supplier with 4 manufacturing offshore plants in Mexico met the requirements for ISO 16945, QS 9000, and internal corp orate policies and procedures necessary retain certification. * Secured ISO Certification by traveling routinely to Mexico, overcoming languag e barriers, and identifying training discrepancies. * Built a solid rapport with the registrar company to ensure company had adequat e time to resolve any problems. * Salvaged an in-jeopardy relationship with a key client-Chrysler, and got them to remove a manufacturing hold. Southwest Research Institute, San Antonio, Texas 2 Years Quality Systems Manager Set up document control, trained a staff of 90+, and ensured the department was on track to earn ISO 9001 certification. * Passed ISO pre-audit. (Left the position before company earned ISO Certificati on.) * Saved $50,000 by facilitating quality systems training necessary to meet ISO r equirements. Data Race, San Antonio, Texas 7 Years ISO Manager/Management Rep Developed, implemented, and managed a quality system start-up for a $140 million company. Managed and assigned day-to-day activities for a staff of 19. Launched several disciplines to support quality systems and save the company thousands o f dollars annually. * Earned ISO 9002 Certification in 18 months, passing audits with flying colors. * Wrote 50 quality system documents.

EDUCATION, MEMBERSHIPS, CERTIFICATIONS & CONTINUING DEVELOPMENT University of Sindh West Pakistan, Jamshoro Degree Program: Bachelor of Science, Business Administration Memberships: * American Society for Quality (ASQ) * Society for Technical Communication (STC) * American Records Management Association (ARMA) Certifications / Continuing Development Coursework: * Lead Auditor Certification; SGS International Certification Services, Texas * Electronics Certificate, Electronic Technology; Edison Technical Institute, Ca lifornia * Certified Auditor; American Society for Quality, Texas * Qualified Trainer, Presentations, Technical Writing; Southwest Research Instit ute, Texas * Project Management; University of Denver, CO * ISO 9000 System Implementation; SGS International Certification Services, Texa s * Technical Writing; University of Texas, Texas * Train the Trainer; University of Florida; Florida * Incident Investigation/Reporting, DMAIC, Critical Thinking, Problem Solving; B axter Healthcare