Quality Manager

What if the work you did every day could impact the lives of people you know? Or all of humanity?At Illumina, we are expanding access to genomic technology to realize health equity for billions of people around the world. Our efforts enable life-changing discoveries that are transforming human health through the early detection and diagnosis of diseases and new treatment options for patients.Working at Illumina means being part of something bigger than yourself. Every person, in every role, has the opportunity to make a difference. Surrounded by extraordinary people, inspiring leaders, and world changing projects, you will do more and become more than you ever thought possible.Position Responsibilities:Work with cross-functionally with PD, LCM, Purchasing, Supply Chain teams to support new product launch. Provide quality support in the areas of design transfer activities by leveraging appropriate quality engineering resource.Oversee operational quality functions including Supplier Quality Management and Product Quality Management. Provide technical support and training to quality team members, ensure quality performance and awareness. Ensure consistency, reliability  and compliance with GMP, Illumina QMS and ISO13485 requirements.Support and drive llumina China MFG quality activities including SCAR, NC and QI/CAPA review, Provide Quality input and approve for Product and Process Change, Review and Approve validation(3Q) protocols, reports and product control related documentation.Lead PMS including product customer complaint, PA issue by pro-active monitoring trend in SFDC.Set up quality metrics and track quality data in order to maintain, improve product and process quality, raise to management in timely manner and drive for continuous corrective and improvement actions.Participate in Quality Management Review, collaborate with counterparts and cross-functional teams at other Illumina sites.All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities.Preferred Education:Bachelor’s degree in biochemical/chemistry/ mechanical engineering  Preferred Requirements:8+ years of relevant experience of quality assurance/ quality control experience in IVD manufacturing environment.Practical experience of in supplier management, process quality control, NC and CAPA.Highly effective communication, facilitation and coaching skills, collaboration on teams in multiple/global locations is desired.Good understanding of GMP and ISO13485.Illumina believes that everyone has the ability to make an impact, and we are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information.