At Intersect ENT, we strive to make localized drug delivery the standard of care in the ear, nose, and throat space. In order to meet that goal, we hire people who like to challenge the status quo, collaborate cross-functionally, and pursue excellence.
Do you embody this spirit of innovation? Are you ready to join our team?
PURPOSE OF JOB:
Support quality assurance and adhere to QSR and ISO regulations.
MAJOR DUTIES AND RESPONSIBILITIES:
- Perform incoming inspection for components.
- Perform device testing to support lot release.
- Perform final packaging inspection and in-process inspection.
- Support day to day manufacturing activities.
- Perform Sterile Load processing and review.
- Perform product retains.
- Assist Quality Engineers, Manufacturing Engineers, and R&D Engineers in developing inspection/test procedures, test method validations, and gage studies.
- Coordinate test requests and shipments to contract laboratories.
- Process RGA product.
- Create and maintain component files and support First Article Inspections.
- Thoroughly document all issues related to quality assurance, QSR, GMP and ISO compliance.
- Support company goals and objectives, policies, and procedures, QSR, and FDA regulations.
- Perform other QA related activities as assigned.
EDUCATION /EXPERIENCE REQUIREMENTS:
- High school diploma. 1-2 years’ related experience in the medical device industry.
- Strong understanding of, cGMP, QSR and ISO13485:2003 requirements.
- Strong knowledge in reading and interpreting technical specifications and mechanical drawings.
- Strong knowledge of a wide variety of inspection and test equipment, and methodologies.
- Strong written and verbal communication skills.
- Strong communications and time management skills required.
- Excellent organizational skills.
PHYSICAL ACTIVITIS AND REQUIREMENTS, VISUAL ACUITY, AND WORKING CONDITIONS:
Physical Activity - Repetitive motions: Making substantial movements (motions) of the wrists, hands, and/or fingers. Fingering: Picking, pinching, typing or otherwise working, primarily with fingers rather than with whole hand or arm as in handling. Talking: Expressing or exchanging ideas by means of the spoken word. Standing: Remaining upright on the feet, particularly for sustained periods of time.
Physical Requirements - Sedentary work: Exerting up to 10 pounds of force occasionally and/or a negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met.
Visual Acuity - The worker is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading; visual inspection involving small defects, small parts, and/or operation of machines (including inspection); using measurement devices; and/or assembly or fabrication of parts at distances close to the eyes.
Working Conditions - The worker is not substantially exposed to adverse environmental conditions (as in typical office or administrative work).
Intersect ENT (NASDAQ: XENT) is a medical technology company dedicated to advancing the treatment of ear, nose, and throat (ENT) conditions through evidence-based innovation. We provide treatments for people with chronic sinusitis, an inflammatory sinus condition that has been shown to substantially reduce quality of life. Sinusitis is one of the most common conditions in the United States.
Intersect ENT is an equal opportunity employer that strives to interview, hire and promote a diverse workforce. All qualified applicants will receive consideration for employment without regard to their race, color, national origin, religion, age, sex, disabilities, veteran status, or sexual orientation.