Job
Description
Role Overview: As a Design Quality Engineer, you will be responsible for developing, establishing, and maintaining quality engineering methodologies, systems, and practices to meet BSC, customer, and regulatory requirements. You will serve as a Quality representative to enhance awareness, visibility, and communication on quality initiatives to support 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. Key Responsibilities: - Work as a part of the sustaining project team and contribute to design quality engineering activities across 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). - Collaborate on product 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 compliance with quality systems and design assurance 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 CAPA systems to meet or exceed internal and external requirements. - Act as an effective communicator or team member to support quality disciplines, decisions, and practices. - Apply 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. - Ability to plan and organize non-routine tasks with approval. - Proficiency in problem-solving and making appropriate decisions in straightforward situations. - Impact quality of own work and the work of others on the team within guidelines and policies. - Ability to explain factual information to others in straightforward situations and present data primarily to internal audiences. Note: No additional details of the company were provided in the job description. Role Overview: As a Design Quality Engineer, you will be responsible for developing, establishing, and maintaining quality engineering methodologies, systems, and practices to meet BSC, customer, and regulatory requirements. You will serve as a Quality representative to enhance awareness, visibility, and communication on quality initiatives to support 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. Key Responsibilities: - Work as a part of the sustaining project team and contribute to design quality engineering activities across 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). - Collaborate on product 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 compliance with quality systems and design assurance 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 CAPA systems to meet or exceed internal and external requirements. - Act as an effective communicator or team member to support quality disciplines, decisions, and practices. - Apply 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. - Ability to plan and organize non-routine tasks with approval. - Proficiency in problem-solving and making appropriate decisions in straigh
