Intersect ENT Inc. Quality Engineer II – Commercial Projects in Menlo Park, California
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:
Responsible for supporting new product development deliverables related to Quality and the successful completion of individual projects. Must establish and maintain quality assurance standards that adhere to the Quality System Regulations (QSR) and International Standards Organization (ISO) regulations. Quality Assurance support for various Quality functions as assigned (e.g. NCMR, Manufacturing Process changes, Verification and Validation, Build Deviations, Material Qualification, First Article Inspection).
MAJOR DUTIES AND RESPONSIBILITIES:
Support the design team by leading quality product-development deliverables (e.g. Risk Analysis, Quality Plan, Validation Master Plan).
Core team Quality Engineer for Commercial Projects (e.g. EU MDR, Risk Management, Quality Plan driven projects).
Support the design team by supporting non-quality product-development deliverables (e.g. Design Description Document, Product Specification).
Perform design and process Failure Modes and Effects Analyses (FMEA) throughout all design phases of the project.
Statistical data analysis and interpretation to support investigations and specification setting activities.
Identify and assist with implementation of preventive and corrective actions via Corrective and Preventive Action (CAPA) procedures, audits, Non-Conforming Material Reports (NCMR).
Ensure that all documents reviewed/ approved follow written procedures, process specifications, and associated external standard requirements.
Support or update documentation (Work Instructions, Standard Operating Procedures) that support the Quality Management System (QMS).
Participate in inspections for Federal Drug Administration (FDA), Food and Drug Branch (FDB), ISO, Medical Device Directive (MDD), and other regulatory agencies.
Periodically support internal audits of Quality owned systems.
Support company goals and objectives, policies and procedures, QSR, and FDA regulations.
EDUCATION /EXPERIENCE REQUIREMENTS:
Bachelor's degree in Engineering (Mechanical, Biomedical, or similar).
Minimum of 2 years’ Quality Engineering experience in medical device, pharmaceutical, or related industry.
Strong written and verbal communication skills.
Strong technical writing skills.
Experience with computer-based applications (MS Word, MS Power Point, MS Excel).
PHYSICAL ACTIVITIES 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.
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.
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, gender identity, or sexual orientation.