James Head
Principal Quality Engineer, Respiratory, Gastrointestinal & Informatics (Rgi) @Covidien Medtronic Minimally Invasive Therapies Group
Signup · Get unlimited contacts
WORK HISTORY
Principal Quality Engineer, Respiratory, Gastrointestinal & Informatics (Rgi) @Covidien Medtronic Minimally Invasive Therapies Group
Boulder, CO
Support of the development and manufacturing of medical devices in conformance with the Quality System Regulations & Medical Device Regulations- Ensure internal Design Control policies and procedures comply with regulations and external standards, including software regulations, risk management, and change controls- Streamlining and continuous improvement of the product development process to ensure robust and efficient development and launch of new and innovative healthcare products.
EDUCATION
World Wide College of Auctioneering
Auctioneering Science
University of Nebraska at Omaha
Bachelor of Science, Biology
University of Phoenix
Masters of Business Administration, Operations
ABOUT JAMES HEAD
Experience working within FDA regulated companies. Can support business functions through diverse roles including Quality, Research & Development, Project Managment and Operations. Specialties- Hands-on experience with Covidien Surgical Solutions product portfolio - ISO13485, ISO14971:2012, FDA/QSR, 60••••23rd edition - Product Risk Management - Project management skills - Developing and implementing strategies - Leadership and team development - Develop and successfully implement strategic metrics - Data analysis - Directing and managing direct reports - Departmental and project budgeting - Detailed reporting and presentation skills
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.