Role: Quality Manufacturing Engineer

Location: Bothell, WA - 98021
Duration: 06 Months

Description:

• Non-Conformance events including CAPA management Partner with Supplier Quality on incoming, outgoing, WIP Partner with Receiving Inspection /WIP inspection / FG Release Design transfer Resolve quality non-conformities with cross-functional stakeholders Quality Management System Improvement Job Overview:
• Responsible with Change Management to manufacturing process or controls and:
• NC/QN Management Process.
• Analysis of defect for determining disposition of non-conformances
• Contribute to Operations performance monitoring, reporting, improvement and development.
• Lead and/or support improvement programs in factory.
• Assists Supplier Quality with investigations and may assist with Supplier Communications, as required.
• Leads change management for process changes in the factory
• Responsible for nonconformance events and investigations -
• Oversees Material Review board activities for nonconformance disposition management
• Acts as advisor to subordinates and cross-functional partners to meet schedules and/or solve technical problems.
• Develops and administers schedules, performance requirements.
• Works on issues of diverse scope where analysis of situation or data requires evaluation of a variety of factors, including an understanding of current business Trends.
• Follows processes and operational policies in selecting methods and techniques for obtaining solutions

Education & Training: -

• Bachelor's degree in engineering science, or equivalent experience - Minimum of 5 years of related engineering experience (medical device or regulated industry preferred).
• Wide-ranging experience within an engineering function.
• Well versed in Quality Engineering and Continuous Improvement techniques.,
• Critical to business, revenue related
• Responsible for NCs, CAPAs and sustaining manufacturing quality activities.
• Delay in hiring will results in compliance issues to NC and CAPAs and sustaining AED product line.