Description

You will manage equipment validation processes and quality control documentation to ensure regulatory compliance.

This role is on-site.

Responsibilities

• Design equipment and material layouts in compliance with ISO, FDA, and GMP standards.
• Prepare and execute IQ, OQ, and PQ protocols for equipment such as centrifuges and incubators.
• Develop strategies to evaluate the precision and accuracy of analytical and production equipment using LIMS.
• Write, review, and approve validation reports, SOPs, CAPAs, deviations, and change controls.
• Travel to various US locations to provide end-user training.

Required Skills

• Minimum 3 months of experience as a Quality, Mechanical Design, or Product Engineer.
• Experience preparing IQ, OQ, and PQ protocols.
• Working knowledge of ISO, FDA, and GMP standards.
• Experience with LIMS (Laboratory Information Management System).
• Ability to draft Medical Device Premarket Applications and Design Control Documents.
• Experience managing Risk Management, Specifications, and Corrective Action Preventative Actions (CAPAs).

Preferred Skills

• BS in Manufacturing, Mechanical, or Industrial Engineering (or foreign equivalent).

Key Skills

Education

ANY GRADUATE