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, a leading global medical technology company. This role is integral to ensuring that quality engineering principles are effectively applied throughout the entire product development lifecycle, from initial research to product launch. The Staff Quality Engineer is responsible for overseeing QA-related research and development activities, ensuring that all quality aspects are meticulously managed and aligned with regulatory standards. This position emphasizes the importance of collaboration and communication within cross-functional teams to drive product quality and compliance. In this role, the Staff Quality Engineer will act as the core team quality representative for design control projects, which includes both new product development and sustaining engineering efforts. The responsibilities encompass managing quality planning, verification and validation processes, risk management, and providing regulatory compliance support. The engineer will work closely with Program Managers to ensure that design deliverables meet the necessary standards for limited commercial and general release. Additionally, the role involves collaborating with Quality Engineers to verify design specifications and requirements effectively. The Staff Quality Engineer will also lead continuous improvement initiatives, actively participate in product requirement development, conduct product system hazard analyses, and facilitate design reviews. A significant aspect of the role includes leading or supporting Corrective and Preventive Action (CAPA) investigations and ensuring that product technical files and Design History Files are complete and auditable. Compliance with Quality System Regulations, ISO, and FDA requirements is paramount, and the engineer will support internal and external audits, product launches, and process improvements while coordinating the resolution of CAPAs and customer complaints. This position requires a proactive approach to engaging with partners to drive consensus and resolve issues promptly. The Staff Quality Engineer will provide statistical support and analytical problem-solving expertise for product-related challenges, serving as a resource for less experienced colleagues.