🛠 Tech Stack

💼 About This Role

You'll join GRAIL's mission to detect cancer early by leading quality operations for complaint handling and post-market surveillance. You'll drive compliance with medical device regulations (ISO 13485, 21 CFR 820, IVDR) and cross-functional improvements. This role stands out for its impact on early cancer detection and work with cutting-edge NGS technology.

🎯 What You'll Do

• Interpret and apply quality concepts per regulatory standards.
• Lead complaint investigations and post-market surveillance activities.
• Perform reportability assessments and trend analysis.
• Drive CAPA and continuous improvement processes.

📋 Requirements

• Bachelor's degree in science, engineering, or technical area.
• 5+ years experience in medical device/pharma quality management.
• Knowledge of ISO 13485, 21 CFR 820, CAP/CLIA regulations.
• Experience supporting regulatory inspections/audits.

✨ Nice to Have

• Experience with Veeva Quality Suites eQMS.
• Experience with Salesforce for complaint handling.