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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
Quality Technician II - 1st Shift
Maple Grove, MNPosted 6 days ago
Full-timeonsitemid