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Boston Scientific · 1 month ago

Quality Technician II - 3rd Shift

Maple Grove, MN

Full-time

Onsite

Entry Level

$42K/yr - $72K/yr

2+ years exp

Boston Scientific is a leader in medical science committed to solving the most important health industry challenges. The Quality Technician II will provide quality support to product development and manufacturing, focusing on quality methodologies from product development through commercialization.

Health CareMedicalMedical Device

No H1B

Responsibilities

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

Qualification

Quality processesCorrectivePreventive ActionStatistical analysisData managementContinuous improvementTechnical writingCommunication skillsTeam collaborationProblem-solving