Director of Quality

About Visby Visby Medical is an ambitious, well-funded late-stage biotech startup. Driven by a belief that infectious disease diagnosis should be quick, accurate, and accessible to all, Visby has developed the world’s first single-use PCR platform that disrupts the traditional model and redefines the way infectious disease is tested and treated. $200,000 - $250,000 a year (This role requires hybrid onsite presence at our San Jose, CA office, and we are unable to accommodate exceptions.) About the Job The Director of Quality plays a pivotal role in ensuring that Visby’s products meet the highest standards of quality, safety, and compliance. You will lead and participate in all aspects of the quality management system (QMS) and work closely with cross-functional teams to drive continuous improvement and maintain compliance with the QMS throughout the product lifecycle. A critical aspect is to establish and oversee supplier quality of an overseas contractor manufacturer, including supporting the design transfer process. The position requires significant international travel to conduct audits and build relationships with suppliers. How You’ll Make an Impact The Director of Quality plays a pivotal role in ensuring that Visby’s products meet the highest standards for quality, safety and compliance. You will lead a team composed of quality professionals and foster a culture of continuous improvement and collaboration within the organization. How Your Position will Impact Product Quality and Achievement of the Quality Objectives You will provide the strategic framework and governance necessary to embed quality in every stage of the product lifecycle. By aligning quality objectives with business goals you will foster a data-driven culture of continuous improvement and ensure that every shipped product meets the specifications and customer expectations. Responsibilities Maintain a robust and effective QMS that is compliant with relevant regulations (e.g., FDA QSR, ISO 13485) and consensus standards. Serve as the company’s management representative by reporting to top management on the effectiveness of the QMS and the need for any improvements. Ensuring promotion and awareness of the QMS and of applicable regulatory requirements. Actively participate in the day-to-day QMS activities and develop an in-depth knowledge of the drivers of product quality. Stay abreast of changes to relevant quality system regulations and consensus standards and ensure that Visby’s QMS is appropriately updated. Collaborate with supply chain and subject matter experts to ensure the quality and reliability of suppliers and contractor manufacturers through the use of supplier controls. Ensure that effective supplier quality agreements are developed and implemented with suppliers and contractor manufacturers, including those located outside the United States. Ensure that risk management activities are effectively used to drive improvement to product quality throughout the product life cycle. Oversee software quality assurance, including software verification activities and collaborating with stakeholders to ensure implementation of cybersecurity requirements. Oversee an efficient and effective document control system. Ensure that quality audits are planned, conducted and that effective corrective actions are taken when needed. Serve as the company point of contact with external quality system auditors (e.g., FDA). Ensure effective quality system training and establish metrics to monitor training effectiveness. Ensure efficient and effective quality control processes and procedures, including use of appropriate sampling techniques. Foster a culture of quality throughout the organization by promoting awareness, accountability and continuous improvement. On Your First Day We’d Like You to Have A bachelor’s degree in engineering, life science or a related field, an advanced degree preferred. A minimum of 8+ years of quality system management experience, preferably in in vitro diagnostics. In-depth knowledge of relevant regulations and standards (e.g., FDA QSMR, ISO 13485) Demonstrated ability to effectively manage supplier quality. Experience with technology transfer and process validation in remote or outsourced manufacturing environments. Willingness to travel internationally as needed to support supply quality. Strong understanding of risk management principles and practices. Proven ability to work with a cross-functional team. It’s Great If You Have Experience with software quality assurance, including cybersecurity. Experience with molecular infectious disease testing. More About the Team You will lead a team of quality professionals, including quality engineers, software quality engineers, and document control specialists. The team works collaboratively to ensure compliance with the quality system while meeting business objectives. More about our benefits Visby offers highly competitive health insurance through United Healthcare or Kaiser, including a company-funded HSA option. We also offer flexible paid time off, 10 company holidays, and many other contemporary benefits and perks. Visby is a proud recipient of the 2023 Cigna Healthy Workforce Designation. Additional information We believe that the unique contributions of all Visbees is the driver of our success. To make sure that our products and culture continue to incorporate everyone's perspectives and experience we never discriminate on the basis of race, color, religion, creed, national origin, ancestry, sex, gender, pregnancy or related medical conditions, sexual orientation, gender identity or expression, age, disability, medical condition, genetic information, marital status, or military or veteran status. FullCOVID Vaccination Required - Reasonable accommodations for medical or religious reasons considered. #J-18808-Ljbffr