Quality Systems Manager

📋 Description

• Manage Quality Systems activities in accordance with organizational policies and applicable medical
• Serve as the primary Quality Systems contact for internal stakeholders, supporting coordination
• Manage communications with physicians regarding returned product analysis test results
• Lead and support cross-functional teams to ensure product quality and distribution activities
• Implement, maintain, and improve quality processes and procedures, including internal audits
• Manage external contract design and manufacturing organizations (CMDOs) in collaboration with the

🎯 Requirements

• Bachelor's degree in Engineering, Computer Science, Physics, Life Sciences, or a related technical
• 5–10 years of experience in a medical device, pharmaceutical, biomedical, or other regulated
• Experience supporting quality engineering activities within a regulated product environment
• Strong understanding of risk management, supplier quality, complaint management, and Quality
• Ability to communicate technical and regulatory requirements effectively across different
• Familiarity with configuration and change management practices

🎁 Benefits

• Remote position based out of Lake Oswego, Oregon
• Full-time, permanent position
• Standard Monday-to-Friday schedule, with hours adapted to the time zones supported
• Limited and occasional travel for assigned projects, meetings, or events
• Equal Opportunity: All qualified applicants receive consideration without discrimination based on