Quality & Compliance Manager

Did you know ...?

Dutch Ophthalmic USA is part of DORC, short for Dutch Ophthalmic Research Center, manufactures equipment, instruments and liquids used in eye surgery.

Every single day our employees ensure that eye surgeons all over the world enjoy the use of innovative ophthalmic devices, instruments, and liquids. DORC uses cutting-edge technology, works closely with innovative surgeons, and thrives to make a difference. Ophthalmologists worldwide use our advanced Ophthalmic surgery unit EVA to take care of their patients to help them see again.

DORC is a ZEISS company, an internationally leading technology enterprise that develops, manufactures and sells highly innovative products and solutions in a variety of business fields, such as medical technology. As a company wholly owned by a foundation, ZEISS is rooted in and committed to responsibility in all its activities.

What is the role?

As Quality & Compliance Manager, you will be responsible for leading and overseeing the Quality Management System (QMS) across three US entities, ensuring harmonization while maintaining compliance with FDA, ISO 13485, and applicable federal and state regulations governing medical device and pharmaceutical distribution activities.

This role defines and executes the regional quality and compliance strategy, serves as the US Management Representative and primary liaison with regulatory authorities, and ensures that products released to the US market meet all regulatory and quality requirements. The position drives continuous improvement, audit readiness, effective corrective and preventive actions, and provides leadership to the quality team to sustain best-in-class compliance performance.