Boston Scientific
Quality Eng - P3
Design Quality Engineer reporting to the Quality department at the Neuromodulation division but based at the manufacturing site location to be a liaison and on-site support for commercial/sustaining and new product development. This role ensures a high-quality standard is maintained for products, documentation, compliance, and most importantly, patients. Critical thinking, multi-tasking, and problem solving are essential skills to be successful. Demonstrates commitment to the Quality Policy (patient safety and product quality) through their daily execution of sound quality practices and the maintenance of an effective quality system. Understands and complies with all the regulations governing the quality systems. Ensures their direct reports are aware of their commitment to patient safety and product quality, are current with their training requirements and that they understand and comply with all other regulations governing their work. Responsibilities: Quality Assurance support for Neuromodulation commercial products, with a focus on Non-Conformance Event Prevention (NCEP) and Correction and Preventive Action (CAPA). Collaborate with functional team members to perform product failure and complaint investigations for complaints, NCEP, CAPA, and/or audit findings. Coordinate product containment tasks for impacted materials and document activities. Assess product, packaging, and labeling design change impacts and risks. Design and implement Quality System processes, procedures, and techniques such as risk assessments, root cause analysis, etc. Represent as a design/quality resource for the Neuromodulation division at the manufacturing site. Communicate, coordinate, and act as a liaison between design and manufacturing. Collaborate with Operations teams to resolve product and process issues. Assess component criticality based on risk criteria and information. Work with supplier management teams to coordinate/assess supplier issues, process changes, and new supplier qualifications. Monitor and track the progress of quality-related tasks and initiatives. Collaborate and follow up with team members to ensure completion of assigned tasks within established timelines. Primary technologies/products of responsibility will be surgical accessories/tools and leads used for Spinal Cord Stimulation (SCS) and Deep Brain Stimulation (DBS). What we're looking for: Basic Requirements: BS Degree in engineering and 4+ years of experience or an equivalent combination of education and work experience. 2-5 years' experience in the medical device industry with a solid understanding of Quality System requirements Excellent verbal and written communication skills Proficiency in MS-Office (Word, Excel, PowerPoint, Project, Visio) Strong technical writing skills and ability to clearly communicate complex information Preferred Requirements: Project/task management experience Experience with Product Lifecycle Management systems (i.e. Windchill, PLM) Experience with nonconformance and/or CAPA process
Design Quality Engineer reporting to the Quality department at the Neuromodulation division but based at the manufacturing site location to be a liaison and on-site support for commercial/sustaining and new product development. This role ensures a high-quality standard is maintained for products, documentation, compliance, and most importantly, patients. Critical thinking, multi-tasking, and problem solving are essential skills to be successful. Demonstrates commitment to the Quality Policy (patient safety and product quality) through their daily execution of sound quality practices and the maintenance of an effective quality system. Understands and complies with all the regulations governing the quality systems. Ensures their direct reports are aware of their commitment to patient safety and product quality, are current with their training requirements and that they understand and comply with all other regulations governing their work. Responsibilities: Quality Assurance support for Neuromodulation commercial products, with a focus on Non-Conformance Event Prevention (NCEP) and Correction and Preventive Action (CAPA). Collaborate with functional team members to perform product failure and complaint investigations for complaints, NCEP, CAPA, and/or audit findings. Coordinate product containment tasks for impacted materials and document activities. Assess product, packaging, and labeling design change impacts and risks. Design and implement Quality System processes, procedures, and techniques such as risk assessments, root cause analysis, etc. Represent as a design/quality resource for the Neuromodulation division at the manufacturing site. Communicate, coordinate, and act as a liaison between design and manufacturing. Collaborate with Operations teams to resolve product and process issues. Assess component criticality based on risk criteria and information. Work with supplier management teams to coordinate/assess supplier issues, process changes, and new supplier qualifications. Monitor and track the progress of quality-related tasks and initiatives. Collaborate and follow up with team members to ensure completion of assigned tasks within established timelines. Primary technologies/products of responsibility will be surgical accessories/tools and leads used for Spinal Cord Stimulation (SCS) and Deep Brain Stimulation (DBS). What we're looking for: Basic Requirements: BS Degree in engineering and 4+ years of experience or an equivalent combination of education and work experience. 2-5 years' experience in the medical device industry with a solid understanding of Quality System requirements Excellent verbal and written communication skills Proficiency in MS-Office (Word, Excel, PowerPoint, Project, Visio) Strong technical writing skills and ability to clearly communicate complex information Preferred Requirements: Project/task management experience Experience with Product Lifecycle Management systems (i.e. Windchill, PLM) Experience with nonconformance and/or CAPA process