Quality Technician II - 1st Shift

Additional Location(s): N/A

Shift: 1st Shift: 5:00 am - 3:00 pm, Monday - Thursday

Role:
Provide quality support to product development and manufacturing. Develop, apply, monitor, measure, improve, and communicate quality methodologies from product development through product commercialization.

• 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 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 investigating and disposing 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 teams

• 2 years of experience with a high school diploma/degree/equivalent

This role is safety-sensitive and requires a pre‑employment drug test.