Responsible for design and implementation of policies and procedures to insure quality and regulatory standards are met; that company products meet defined and documented specifications; and that they comply with applicable Federal, State and International regulations and standards governing the medical device industry, including but not limited to Federal Food and Drug Administration (FDA), European Medical Device Regulation (MDR), Canadian Medical Device Regulations, International Standards Organization (ISO), Underwriter's Laboratories (UL), U.S. Occupational Safety and Health Administration (OSHA), U.S. Environmental Protection Agency (EPA), American Society of Testing and Materials (ASTM), American National Standards Institute (ANSI). Oversee testing of processes and products. Leads and directs the works of others.
Bachelor's degree from accredited college or university; with 10 years related medical device experience; or equivalent combination of education and experience is required.
Advanced degree a plus.
Experience in regulatory submissions (510k's) a plus.
ASQC CQM a plus.
Thorough understanding of FDA QSR as applicable to company business; knowledge of ASTM, ISO, UL, CSA, ANSI, EPA, MDSAP, MDR, 21 CFR 800-860 and U.S. Customs Regulations as applicable to company business.
Must be able to prioritize, organize, and delegate assignments and handle multiple tasks / projects simultaneously.