Quality Engineer - Foldax Job Description The Quality Engineer provides support for manufacturing and R&D quality assurance activities for Class III Medical Devices. The role contributes to CAPA and NCR systems, and process and design verification and validation activities. Responsibilities Monitor outgoing product quality levels via review of nonconforming reports, CAPAs, and complaint records. Develop and execute validation protocols (IQ/OQ/PQ) for manufacturing equipment, processes, and software systems. Develop and execute Test Method Validations for manufacturing processes and laboratory equipment. Improve Quality System through internal audits and compliance audits. Works effectively with colleagues in cross-functional or departmental team projects. Other responsibilities as assigned. Requirements and Qualifications 0-2 years of quality, manufacturing, engineering, inspection, or regulated-industry experience preferred. Good verbal and written communication skills Working knowledge of spreadsheets, such as excel, and Microsoft office programs Experience working with CAPAs, NCRs, and within a regulated industry is preferred Physical Requirements and Work Environment This job operates in a professional office environment and routinely uses standard office equipment. May perform work in a clean room environment. While performing the duties of this job, the employee may be required to sit or stand for long periods of time; depending on the machine they are operating. Must be able to occasionally move and lift objects of up to 25 lbs. Additional Information The primary work location for this position is Salt Lake City, UT. This is a 100% on-site position. Less than 10% travel required.

Job Type:

Full-time Benefits:

401(k) Dental insurance Health insurance Life insurance Paid time off Vision insurance

Schedule:

Monday to Friday Why Join Us Make a direct impact on life-saving cardiovascular technology. Work at the forefront of innovative polymeric medical device manufacturing. Grow your career in a collaborative, fast-moving, and mission-driven environment.

Job Type:

Full-time Pay:

From $70,000.00 per year

Benefits:

401(k) Dental insurance Health insurance Paid time off Vision insurance

Work Location:

In person