Quality Assurance Specialist

CorDx a multi-national biotech organization focused on pushing the limits of innovation and supply in global health. With over 2,100 employees across the world, serving millions of users in over 100 countries, CorDx delivers rapid testing and point-of-care medical device solutions used in the detection of infectious disease such as COVID-19, pregnancy, drugs of abuse, biomarkers, and more. CorDx is at the cutting edge of technology, artificial intelligence, and data science with the goal of delivering diagnostic solutions to some of the most critical questions in healthcare. Position: Quality Assurance Specialist Position Type: 5 days Onsite Exempt Position Key Responsibilities Support the Quality Management System (QMS) in accordance with ISO 13485 and applicable regulatory requirements. Report to the Quality Manager/Supervisor, provide timely status updates, and complete assigned tasks on schedule. Review and maintain QC and quality records, including inspection records and batch documentation. Assist in identifying nonconformities and support investigation and corrective action activities under supervision. Support equipment qualification and validation documentation activities. Assist with drafting and updating SOPs and quality record forms as needed. Use the company’s eQMS for document control, training records, and CAPA/change management support. Support internal and external audits and related follow-up activities. Collaborate with QC, production, and other departments to support quality compliance and daily operations. Required Qualifications 1–3 years of experience in Quality Assurance and/or Quality Control, preferably in IVD or medical device manufacturing. Basic working knowledge of ISO 13485 and quality system requirements. Experience reviewing quality records and maintaining documentation. Familiarity with eQMS systems preferred. Exposure to equipment validation activities is a plus. Good written and verbal communication skills, with the ability to follow instructions and report progress clearly. Strong sense of responsibility, timely task execution, and a positive work attitude. Competitive compensation package. 401(k) plan with company contributions. Flexible paid time off (PTO) policy. Equal Opportunity Statement We are an equal opportunity employer committed to inclusion and diversity. We do not discriminate based on race, gender, religion, sexual orientation, age, color, marital status, veteran status, disability status, national origin, or any other protected characteristic. #J-18808-Ljbffr