BD - San Diego, CA
posted about 2 months ago
The Staff Quality Engineer is a pivotal member of the New Product Development Team at BD, one of the largest global medical technology companies. This role is integral to ensuring that quality engineering principles are effectively applied throughout the new product development process and sustaining engineering projects. The Staff Quality Engineer is responsible for overseeing QA-related research and development activities from the initial research phase through to product launch. This position requires a deep understanding of quality systems and regulatory standards, as well as the ability to manage all quality aspects of the design control process, including quality planning, verification and validation planning, risk management, and regulatory compliance support. In this role, the Staff Quality Engineer will act as the core team quality representative for design control projects, ensuring that all design deliverables are met and can be released for limited or general commercial use. The engineer will collaborate closely with Program Managers and Quality Engineers to ensure effective verification of design specifications and requirements. Additionally, the Staff Quality Engineer will drive continuous improvement efforts by facilitating and collaborating with cross-functional teams, actively participating in product requirement development, product system hazard analysis, and design reviews. The position also involves leading or supporting Corrective and Preventive Action (CAPA) investigations and closures, ensuring that product technical files and Design History Files are complete and auditable. Compliance with ISO and FDA requirements is critical, and the Staff Quality Engineer will support internal and external audits, participate in teams, and coordinate the resolution of CAPAs, product quality notifications, change notifications, and customer complaints. The role requires proactive engagement with partners to drive consensus and resolve issues in a timely manner, as well as providing statistical support and analytical problem-solving expertise for product-related challenges. This position also serves as a resource for colleagues with less experience, fostering a collaborative and supportive work environment.