NOTE THAT THIS IS NOT AN IT POSITION AND WE ARE STRICTLY LOOKING FOR SOMEONE WITH EXPERIENCE IN MEDICAL DEVICE AND MANUFACTURING COMPANY.
** MUST BE LOCATED NEAR Alpharetta - WILL BE GOING TO PLANT SITE TO WORK EVENTUALLY **
This role will be primarily responsible for integration and remediation activities related to a new acquisition. This role will be responsible for planning, directing, and coordinating preparation and implementation programs to ensure compliance with company’s quality processes and procedures.
• Reviews and thoroughly understands product functional and design specifications.
• Devises and implements methods and procedures for inspecting, testing, and evaluating the precision and accuracy of products and production equipment.
• Designs or specifies inspection and testing mechanisms and equipment.
• Conducts quality assurance tests
• Performs statistical analysis to assess the cost of, and determine the responsibility for, products or materials that do not meet required standards and specifications
• Performs defect analysis utilizing experience in statistical quality process analytical methods
• Prepares and maintains a variety of reports; manages documentation control systems
• Implements changes to the quality management system through procedure and process updates
• Communicates and resolves QA issues with production and quality technicians on a day-to-day basis
• Performs validation activities including protocol/report writing, review and approval of such documents, and overall maintenance of program
• Prioritizes and manages multiple projects within design specifications and budget restrictions
• Investigates and thoroughly understands developments in quality assurance codes and standards
•Responsible for developing and implementing professional training
• Setting Daily/Weekly priorities
• Other duties as assigned by manager
• Has the independence and authority to perform required tasks to ensure all provisions of the quality system are met
• Commitment to excellence and high standards
• Excellent written and oral communication skills in English
• Strong organizational, problem-solving, and analytical skills
• Ability to manage priorities and workflow
• Versatility, flexibility, and a willingness to work within constantly changing priorities with enthusiasm
• Acute attention to detail
• Demonstrated ability to plan and organize projects
• Proficient on Microsoft Office (Word, Excel, Project and PowerPoint)
• Proven ability to handle multiple projects and meet deadlines
• Good judgment with the ability to make timely and sound decisions
• Competent understanding of ISO 9001, ISO 13485 and GMP regulations
• Familiar with Design and Risk Control principles
• Creative, flexible, and innovative team player
• Working knowledge and understanding of the basic principles, theories, concepts, and practices in the applicable area of synthetic cartilage implant products and instrumentation
• Quality Engineer certification desired
• Basic PC skills
Global Medical Device Manufacturing Company
Why Work Here?Company is one of the world’s leading medical technology companies and is dedicated to helping healthcare professionals perform their jobs more efficiently while enhancing patient care. Offering a diverse array of innovative medical technologies, including reconstructive, medical and surgical, and neuro-technology & spine products to help people lead more active and more satisfying lives
Company offers Meaningful innovation, Growth and Opportunity. It's most Admired Company in Medical Products and Equipment since 2005