Description

You will manage quality compliance and validation processes within a regulated environment.

This role is on-site.

Responsibilities

• Review and execute validation and change control documents.
• Author SOPs and protocols, including IQ, OQ, and PQ for process control systems.
• Apply quality regulations and standards to existing workflows.
• Manage quality-related projects through their lifecycle.

Required Skills

• 10+ years of experience in a related field or a Bachelor’s Degree in a scientific or technical discipline.
• 1+ year of experience in a regulated environment, preferably medical devices.
• Knowledge of quality system processes and GMP regulations.
• Experience with 21CFR 820, ISO 13485, ISO 14971, IEC62304, and ISO 27001.
• Proficiency in authoring SOPs and change control documentation.
• Ability to execute IQ, OQ, and PQ protocols.
• Proven project management skills.

Preferred Skills

• Experience with IEC62304.
• Knowledge of ISO 27001.

Key Skills

Education

Any Graduate