Quality Engineer 4
Business Unit: Ultrasound
Requisition Number: 222765
Primary Location: United States-Washington-Issaquah
Assignment Category: Full-time regular
Experience Level: Senior level
Education Required Level: Bachelor's Degree
Travel Required: 5%
Siemens Ultrasound is seeking an energetic and highly motivated Sr. Quality Engineer who will be responsible for supporting the Product Development Process as a member of the Quality group. This position is responsible for ensuring project Quality including reliability and compliant design control practices.
• Partner with cross-functional leadership to ensure all aspects of Product Development are performed in conformance to the quality management system and regulatory requirements
• Accountable for Quality of Ultrasound products, and execution of continuous improvement for projects, supplier Quality initiatives and process improvement/development project(s).
• Engage and understand the industry environment for Ultrasound best practices and be able to execute and implement those requirements as the business dictates. Specifically these areas include Engineering (process, material and product design), Quality (Six Sigma, DOE, Validation, etc.) and Documentation (Operating procedures, Contracts, Agreements, Training, etc.).
• Review product lifecycle documentation against product and process requirements using specifications, materials, tools, techniques, and methodologies in accordance with applicable procedures and standards
• Identify, report and follow-up on process adherence issues
• Improve customer satisfaction through Quality initiatives and continuous process improvements
• Ensure process harmonization in a global environment
• Update existing processes, and develop new ones as required
• Train the organization on new and updated processes
• Execute mock-audits, report findings and follow up on issues
• Working knowledge of medical device requirements including: Quality System Regulation (QSR 21 CFR 820), Canadian Medical Device Regulations, IEC 62304, ISO 13485, ISO 14971 and IEC 62366
• 5+ years Quality Engineering experience in a GMP environment or highly regulated industry
• Bachelor's Degree in Electrical Engineering, Computer Engineering or equivalent technical Degree; or equivalent combination of education and experience
• Demonstrated ability to handle highly confidential information appropriately.
• Excellent analytical skills
• Quality/Reliability Engineering expertise
• High level of initiative with ability to self-manage
• Strong interpersonal skills with ability to work independently and as part of a team
• ASQ certification and or ISO 13485 Lead Auditor certification a plus