Successful candidates will have demonstrated skill and experience in implementing and maintaining quality system requirements including documenting procedures, document control, MRB, and other related quality processes, and have a proven track record of hands-on implementation and support of ISO 9001 and ISO 13485 quality system procedures and practices.
· Thorough understanding of continuous process improvement tools.
· Detailed knowledge and experience with implementation and management of ISO 9001 and ISO 13485 quality systems.
· Three or more years experience at supervisory or managerial levels of Quality Assurance in a manufacturing environment.
· Ability to interact with all levels of the organization to promote and improve product and process quality.
· Good communication skills both verbally and in writing.
· Bachelor’s degree in Science, Engineering or a related discipline, or equivalent qualifications based on demonstrated experience.
· Internal Auditor training and certification to ISO 9001:2015 and/or ISO 13485:2016