Description

You will lead the qualification and validation of medical device equipment during a facility relocation. Your primary focus is ensuring all assets meet regulatory standards through rigorous testing and documentation.

Responsibilities

• Write and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols.
• Manage the end-to-end validation lifecycle, from protocol creation to final reporting.
• Support the physical move and reinstallation of equipment at the new site.
• Ensure all validation activities comply with medical device regulatory requirements.

Required Skills

• 5+ years of experience in equipment validation or qualification.
• Deep expertise in IQ, OQ, and PQ methodologies.
• Proven track record in protocol creation, execution, and reporting.
• Must have direct experience in the medical device industry.
• Strong understanding of equipment qualification standards.

Preferred Skills

• Experience with catheter manufacturing or related medical device technologies.

Key Skills

Education

Any Graduate