Design Quality Engineer

As a Design Quality Engineer at our company, your primary responsibility will be to develop, establish, and maintain quality engineering methodologies, systems, and practices that align with BSC, customer, and regulatory requirements. You will serve as a Quality representative to enhance awareness, visibility, and communication on quality initiatives, supporting departmental, functional, site, divisional, and corporate quality goals and priorities. Your role will involve providing focused quality engineering support within new product development, operational, or system/services support. In this position, you will collaborate with sustaining project teams and engage in design quality engineering throughout the entire product cycle. Your duties will include ensuring the creation and proper execution of Project/Sustaining Quality Deliverables, such as Project Design & Development Plan, Risk Management Plan, Hazard Analysis, Use and Design FMEA, Field Assessment Plan, and Software Validation Plan. Additionally, you will work on product Design History File (DHF), design input, design output, product risk management, usability, verification, and validation efforts for commercial products. Furthermore, you will be responsible for managing electronic document control and version control on all project-related documents, ensuring adherence to quality systems and design assurance Standard Operating Procedures (SOPs), and providing quality and regulatory compliance guidance to product development or design change project teams. You will lead the implementation of assurances, process controls, and Corrective and Preventive Action (CAPA) systems to meet or exceed internal and external requirements. As an effective communicator and team member, you will support quality disciplines, decisions, and practices while applying sound, systematic problem-solving methodologies to identify, prioritize, communicate, and resolve quality issues. Your role will also involve assisting in the development and execution of streamlined business systems to effectively identify and address quality issues. In all your actions, you will demonstrate a primary commitment to patient safety and product quality by maintaining compliance with the Quality Policy and all other documented quality processes and procedures. As a Design Quality Engineer, you will be expected to have expanded conceptual and technical knowledge in the Medical Device Design Quality domain, broaden your capabilities in applying concepts in your job function, demonstrate working knowledge of business and industry practices, and company processes to accomplish your work. You will be accountable for your contributions and meeting objectives, with no supervisory responsibility. Your role will involve planning and organizing non-routine tasks with approval, initiating or maintaining work schedule and priorities, organizing project assignments, and maintaining project schedules. You will use judgment to solve problems in straightforward situations, working under general direction from more senior-level roles or managers. Your interactions and communications will primarily involve explaining factual information of limited complexity to others in straightforward situations and organizing, presenting, and explaining data/information to internal audiences.,