Quality Assurance Professional

DANNY KYLE

***** ** ***** ** / *****, Oklahoma **099 / 405-***-**** / ********@*******.***

Quality Engineer

Quality Systems Development and Implementation / Risk Management / Continuous Improvement / Error Reduction / cGMP Compliance / Supplier Evaluation / Root Cause and Corrective Action / Internal Audit / Product Development / Lean Six Sigma Principles

Systems Development and Implementation: I have been fortunate to experience taking part in the development and implementation of cGMP quality, manufacturing and operational systems for medical device manufacturing companies that manufacture and distribute products which range from diagnostics equipment to radioactive, sterile, implantable devices.

Operations and Quality Management: Over the last nine years I have utilized progressive management skills and experience that was gained during the growth of a medical device manufacturing company from its initial product launch to grossing over $20 million in annual sales.

Proven Record - Across All Quality System Functions: I have been responsible for the development and implementation of quality system functions which include; customer complaint investigation, incoming material inspection and release, equipment calibration and tracking, corrective and preventive action, risk management, etc. and have been involved in product development and design validation.

Extensive Quality Systems Knowledge: I have twelve years experience working within cGMP regulated manufacturing facilities. Nine of those years were spent developing, implementing and managing systems that complied with FDA 21CFR820 Quality System Regulation, ISO13485:2003, Canadian Medical Device Conformity Assessment System, Medical Device Directive 94/42/EEC, ISO14971/2007 and other associated ISO standards for the manufacture and distribution of terminally sterilized, medical devices.

BS – Biology Major / Chemistry Minor, Northeastern State University

Selected Achievements & Skills

□ Managed the development of a risk based vendor approval process I led and managed the development and implementation of a risk based vendor approval process which provided a robust system for assigning risk to purchased items and services which were then mitigated through vendor and quality inspection controls.

□ Implemented processes which allowed for zero significant findings from FDA and OK DEQ inspections as well as ISO 9001:2000/ISO 13485 audits over nine years of operation. I was part of a two person team who established and implemented the organization’s quality system processes that complied with cGMP, NRC and ISO industry requirements.

□ Part of the team which established an internal process for the onsite and offsite terminal sterilization of products. I was a key player in the development of a product terminal sterilization program which allowed for the ethylene oxide sterilization of onsite products within an ISO Class 7 controlled environment and the gamma irradiation sterilization of offsite products. I also developed the validation program for the organization’s sterilization processes.

□ Skills: Exceptionally strong written and verbal communication skills. Highly personable and capable of working with executive management and cross functionally within the organization. Adept at solving complex problems by determining root cause and corrective action to prevent recurrence. Technical skills which include the use of most Microsoft Office products including Excel for trend analysis and statistical process control as well as equipment qualification and process validation. Process and procedure development and implementation skills.

Career Overview

□ Core Oncology, Inc. (formerly Mills Biopharmaceuticals, LLC) – Associated with the medical device manufacturing company from 2007 to 2009. Progressed through the positions of Vice President of Manufacturing Operations and Director of Quality and Regulatory Affairs

□ Mills Biopharmaceuticals, LLC - Associated with the medical device manufacturing company from 2000 to 2007.Progressed through the positions of Quality Manager, Quality Supervisor and Technician.

□ Organon Teknika – Quality Control Specialist 1997-1999

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