Design Quality Engineer

Who We Are

ABOUT ENOVIS

Enovis Corporation (NYSE : ENOV) is an innovation-driven medical technology growth company dedicated to developing clinically differentiated solutions that generate measurably better patient outcomes and transform workflows. Powered by a culture of continuous improvement, global talent and innovation, the Company's extensive range of products, services and integrated technologies fuels active lifestyles in orthopedics and beyond. For more information about Enovis, please visit www.enovis.com .

What You'll Do

Summary :

The Design Quality Engineer position is responsible to implement and lead Design Quality Engineering activities at the DJO design and production location(s) as assigned. The Design Quality Engineer will support priority Product Development and Sustaining Design Engineering projects as the lead Quality Engineering technical representative. This position will be responsible to assure product designs meet our compliance with FDA regulations, ISO 13485 and global regulatory standards and Company strategies. The position will report directly to the Manager of Design Quality.

Essential Duties and Responsibilities :

• Assists process owners to write and issue procedures to assure compliance with the current FDA QSR regulations, ISO 13485, CMDR and Medical Device Directive requirements; and to provide training to process owners related to Quality Management System requirements, as necessary. By the way of example and not exclusion, process may include Standard Operating Procedures (SOP's) manufacturing and design processes, inspection procedure and test procedures. Review and approve completed procedures to assure compliance with content and regulatory requirements.
• Support Design Quality Engineering Assignments, including New Product Introduction (NPI) projects, Corporate priority projects and sustaining support. Quality Engineering Responsibilities may include :

Support, Review and Approve Design Specification packages

Perform Design History File audits at Phase Gates to ensure product development projects are in compliance to applicable design control regulations and company policies and procedures.

Lead Supplier Corrective Action program, communicating and coordinating CAPA completion of suppliers.

Conduct interviews, summarize observations, conduct closing meeting with Department Supervisors

Education / Experience :

Skills and Technical Requirements :

EOE AA M / F / VET / Disability Statement

All qualified applicants will receive consideration for employment and will not be discriminated against on the basis of race, religion, color, national origin, sex, protected veteran status, disability, or any other basis protected by federal, state or local laws.