Validation Lead

Key Responsibilities :

Lead validation activities for medical device systems, tools, and software across multiple projects.

Develop and review Validation Plans, Protocols, and Reports.

Ensure validation processes comply with medical device regulatory standards and Quality Management Systems.

Review test strategies, validation protocols, and test evidence to ensure completeness and compliance.

Coordinate with cross-functional teams including R&D, Quality, Regulatory, and Program Management to align validation deliverables with project timelines.

Support design controls and validation documentation as per regulatory guidelines.

Conduct risk assessments and impact analysis related to validation activities.

Ensure traceability between requirements, risks, test cases, and validation results.

Support internal and external audits by ensuring validation documentation is complete a...