Job Description
Duties & Responsibilities:
• Review and approve design requirements and design changes to ensure appropriate validation and verification (V&V) requirements are met.
• Collaborate cross-functionally to create and maintain risk management files and documents.
• Ensure all risk assessments are updated concurrently with design changes.
• Manage and maintain Design History Files (DHF).
• Perform routine DHF audits to ensure continuous compliance.
• Create and maintain quality documentation, including quality plans, procedures, and reports.
• Review and approve Test Method Validation (TMV) protocols and reports (e.g., Gage R&R) to ensure measurement systems are reliable prior to V&V execution.
• Monitor post-market feedback for early-stage products to ensure stable field performance, generating summary reports, and field feedback reviews.
• Stay up to date with industry standards and regulations related to medical device quality and implement...