Quality Engineer

This position is a key individual contributor in the Quality Operations organization, responsible for

executing quality management system (QMS). Primary responsibilities include reviewing

and dispositioning quality records associated with equipment controls against the governing

procedural requirements, and performing acceptance activities including incoming and finished

product release following the applicable procedural requirements. This individual contributes to a

positive environment of accountability and performance excellence.

Responsibilities (General):

Support Quality Operations through execution of quality engineering concepts and

principles in accordance with quality management system and regulatory

requirements including ISO 13485, ISO 14971, 21 CFR 820, IVDR, and related regulations

and standards.

Demonstrate technical proficiency, creativity, teamwork, collaboration with others.

Complete assignments timely and of high quality, effectively communicating status and

issues with management.

Responsibilities (Specific):

Facilitate equipment qualification as well as related activities as assigned.

Support acceptance activities including incoming inspection and finished product inspection

focusing on the Raleigh, NC site and other activities as assigned.

Other duties as assigned.

Qualifications and experience (Required):

Bachelors degree in science, engineering, or other technical area.

Minimum of 5 years of experience working within a medical device, pharmaceutical, or

biotech quality management system.

Experience working with in vitro diagnostic medical device regulations and standards

including ISO 13485:2016, 21 CFR 820, IVDR, and other applicable industry requirements.

Strong written and verbal communication skills.

Ability to comprehend and interpret technical information.