Design Quality Engineer

Role Overview: As a Design Quality Engineer at Boston Scientific, you will be responsible for developing, establishing, and maintaining quality engineering methodologies to meet BSC, customer, and regulatory requirements. You will play a crucial role in improving awareness, visibility, and communication on quality initiatives to support departmental, functional, site, divisional, and corporate quality goals and priorities. Your primary focus will be providing quality engineering support within new product development, operational, or system/services support. Key Responsibilities: - Participate in sustaining project teams and contribute to design quality engineering throughout the entire product cycle. - Ensure 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 (if applicable). - Work on product Design History File (DHF), design input, design output, product risk management, usability, verification, and validation efforts for commercial products. - Manage electronic document control and version control for all project-related documents. - Ensure adherence to quality systems and design assurance Standard Operating Procedures (SOPs) as per Boston Scientific's PLCP. - Provide guidance on quality and regulatory compliance to product development or design change project teams to ensure country-specific compliance with laws and regulations. - Lead the implementation of assurances, process controls, and Corrective and Preventive Action (CAPA) systems to meet or exceed internal and external requirements. - Act as an effective communicator and team member to support quality disciplines, decisions, and practices. - Utilize sound, systematic problem-solving methodologies to identify, prioritize, communicate, and resolve quality issues. - Assist in the development and execution of streamlined business systems to effectively identify and resolve quality issues. Qualification Required: - Expanded conceptual and technical knowledge in Medical Device Design Quality domain. - Working knowledge of business and industry practices and company processes. - Strong problem-solving skills and the ability to work under general direction. - Ability to impact the quality of work and collaborate effectively with internal stakeholders. Please note that there are no additional details about the company provided in the job description.,