<p>Responsibilities:</p> <ul> <li>Perform incoming inspection of materials and receiving documentation for conformity to specifications. </li><li>Support manufacturing operations through timely review of DHR's including release of finished goods. </li><li>Adhere to good manufacturing practices and good documentation practices. </li><li>Assist Quality Engineers and manufacturing personnel in the execution of calibration activities including review and retrieval of calibrated equipment for processing. </li><li>Positive and cooperative communication and collaboration with all levels of employees, contractors and vendors. </li><li>Assist in both internal and external audit preparation. </li><li>Participate in NCMRs / CAPA's to better improve company practices and systems. </li><li>Perform quarterly Air Sampling / Particle Testing in the Clean Room. </li><li>Other duties as assigned. </li></ul> <p>Requirements:</p> <ul> <li>High School Diploma or equivalent is required. </li><li>Additional training in Quality and/or a focus in medical device preferred. </li><li>1-3 years of experience in a Quality role (medical device preferred, other regulated industries considered). </li><li>Strong working knowledge of Microsoft Word and Excel. </li><li>Understanding of ISO 13485, ISO 14644, and CFR 21-820. </li><li>User experience of QMS, PLM and CMMS systems. </li><li>Organizational skills and attention to detail. </li><li>Ability to read drawings and prints. </li></ul>