Quality Technician II - 1st Shift

Quality Technician II - 1st Shift

Work mode: Onsite Onsite Location(s): Maple Grove, MN, US, 55311 Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we'll help you in advancing your skills and career. 1st Shift: 5:00 am - 3:00 pm, Monday - Thursday About the role: To provide quality support to product development and manufacturing. To develop, apply, monitor, measure, improve, and communicate quality methodologies from product development through product commercialization Work Mode At Boston Scientific, we value collaboration and synergy. This role follows an onsite work model, requiring employees to be in our local office four days per week Relocation Relocation assistance is not available for this position at this time. VISA Boston Scientific will not offer sponsorship or take over sponsorship of an employment VISA for this position at this time. Your responsibilities will include: Provide onsite support for quality-related issues on the manufacturing floor Serve as a subject matter resource for quality processes, offering guidance and support to the business unit. Identify, scope, and contain nonconforming products Communicate quality concerns effectively to stakeholders through clear and timely email updates, ensuring critical information is disseminated appropriately. Review Device History Records (DHR) and acceptance records to confirm all activities outlined in the Device Master Record (DMR) are completed and approved Create and maintain Nonconforming Event and Prevention (NCEP) records, documenting quality issues with precise technical writing. Support Corrective and Preventive Action (CAPA) activities Identify opportunities for improvement and actively participate in continuous improvement initiatives. Perform product and in-process testing, collect and analyze data, and report findings to ensure compliance with quality standards. Assist during internal and external audit activities Conduct product failure analysis to determine root causes and recommend corrective measures. Develop and maintain data files, forms, and documentation systems, ensuring accuracy and accessibility. Utilize documentation systems to research information and generate Change Requests in accordance with established procedures. Train peers on quality processes, methods, and best practices Initiate and assist in the investigation and disposition of nonconforming materials and systems Update and manage databases and spreadsheets to track, monitor, and report departmental activities. Use inventory and traceability management systems to transact and research material movements. Perform basic statistical analysis and communicate results to cross-functional Required qualifications: 2 years of experience with a high school diploma/degree/equivalent