Main Responsibilities and Authority： + Coordinate corporate & external quality system audit, including ISO13485, MDSAP, FDA QSR820, China GMP and Others like Costco GMP audit, etc., and follow up the corrective actions and preventive actions for non-conforming, + Lead implementation of internal quality system audit and the follow up corrective and preventive activities. + Daily maintain and improve the quality system, monitor quality system implementation of each department and Cooperate with Global functions to ensure effective communication and implementation of Global QMS requirements related to local site. + Collect, maintain and understand related legal requirements of company QMS, ensure the legal compliance of company QMS. + Assist relative department for building the quality assurance process/system for the new or change process. + Train newcomers occasionally about company level requirements of quality management system + Company KPI data collection, management and reporting + Continuously contribute, develop and implement ideas that improve performance. + Other tasks assigned by the superior Education： + Bachelor or above in mechanical/electronic field preferred Working Experience ： + Above 5 years relevant working experience, + Good knowledge of ISO9001 、 ISO13485 and MDSAP, and with the capability of planning QMS of medical device industry; + Familiar with FDA QSR820 quality system, and China GMP etc. + Excellent English skill Certificate ： + ID, certification of education. ISO9001 and ISO13485/MDSAP Internal audit certificate Professional Requirement: + Good coordination and communication skill Other Requirement: + High responsibility GN brings people closer through our leading intelligent hearing, audio, video, and gaming solutions. Inspired by people and driven by innovation, we deliver technology that enhance the senses of hearing and sight. We help people with hearing loss overcome real-life challenges, improve communication and collaboration for businesses, and provide great experiences for audio and gaming enthusiasts. GN was founded more than 150 years ago with a vision to connect the world. Today, inspired by our strong heritage, GN touches more lives than ever with the broadest portfolio of products and services in our history – fostering a sense of community, openness, and understanding. By listening to customers and combining our unique expertise in the human ear, audio, video, and speech, wireless technologies, software, and miniaturization, we transform what it takes to bring people closer to what is important to them. **The GN-owned brands that are responsible for bringing these technologies to life:** + Medical grade hearing technology: ReSound (https://www.resound.com/en) , Beltone (https://www.beltone.com/en) , Interton (https://www.interton.com/en) , Jabra (https://www.jabra.com/hearing) + Professional collaboration: Jabra (https://www.jabra.com/) , BlueParrott (https://www.emea.blueparrott.com/) , FalCom (https://falcom.gn.com/) + Gaming, calls and media: SteelSeries (https://steelseries.com/) , Jabra (https://www.jabra.com/) Founded in 1869, the GN Group employs 7,000 people and is listed on Nasdaq Copenhagen (GN.CO). GN’s solutions are sold in around 100 countries across the world. If you would like to learn more about us, visit our homepage gn.com or click on our different brands. You can also connect with us on LinkedIn (https://www.linkedin.com/company/gn-store-nord/) , Facebook (https://www.facebook.com/gnstorenord/) and Twitter (https://twitter.com/gnstorenord) . We are a Equal Opportunity Employer that values a diverse and inclusive workforce. We do not discriminate on the basis of race, color, national origin, religion, age, gender identity, sexual orientation, marital status, disability, genetic information, veteran status, or any other basis prohibited by federal, state, or local law. Women, minorities, veterans, LGBTQIA+ individuals, and persons with disabilities are encouraged to apply. Come join our team!