• Senior Quality Assurance Coordinator

    Integra LifeSciences (Sparks, NV)


    Changing lives. Building Careers.

     

    Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what's possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.

    RESPONSIBILITIES

    To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.

     

    + Perform inspections and tests of finished devices, using appropriate inspection, measurement, and test (IMT) equipment.

    + Review and interpret engineering drawings, material specifications, and test documents (training in technical drawing interpretation will be provided).

    + Collaborate with supply chain and manufacturing teams to plan inspection activities and ensure priorities are achieved.

    + Work in partnership with the 3PL to insure all activities and operations are carried out in compliance with local, state, federal, and international regulations and laws governing the quality operations

    + Develop, review, and approve quality records, including daily inspections, plans, protocols, and reports, supporting GxP manufacturing and development.

    + Perform Quality Investigations in response to quality events (complaints, HHE), use good judgement and a systematic approach to determine appropriate corrections and root cause(s), implement corrective and preventive actions, and keep good records to ensure accurate event reconstruction.

    + Other Duties as assigned

    DESIRED MINIMUM QUALIFICATIONS

    The requirements listed below are representative of the knowledge, skill and/or ability required for his position.

     

    + A minimum of a High School or Trade School diploma combined with a minimum of 3-5 years of quality experience.

    + Ability to track and manage inspection workload and rejected products.

    + Ability to interpret instructions, blueprints, and drawings to effectively inspect product is required.

    + Ability to utilize multiple gauges and measurement tools for inspection of manufactured components

    + Use of math skills relative to physical measurement of product (calculations involving basic functions and metric units) is required.

    + Knowledge of ISO, FDA and QSR concepts and guidelines preferred.

    + Excellent communication and organizational skills.

    + Outstanding attention to detail.

    + Strong interpersonal skills and ability to work with others in a positive and collaborative manner.

    + Demonstrated ability to work accurately, follow instructions/schedules/timelines and handle multiple priorities.

    + Knowledge of various MS Office applications such as: Word, and Excel

    + Must be able to work independently with minimal supervision.

    + Must be able to read and write in English. Must be able to demonstrate comprehension of written English by successfully completing unassisted written tests, including, but not limited to, Work Instructions and Standard Operating Procedures.

    + Must be able to observe company policies and safety procedures at all times.

    + Must be able to give and welcome constructive feedback; contribute to building a positive team spirit.

    + Must be able to treat others with respect; work with integrity and ethically; uphold organizational values.

     

    Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.

     

    This site is governed solely by applicable U.S. laws and governmental regulations. If you'd like more information on your rights under the law, please see the following notices:

     

    EEO Is the Law (https://www.eeoc.gov) | EOE including Disability/Protected Veterans (https://www.eeoc.gov/eeoc/publications/ada\_veterans\_employers.cfm)

     

    Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA (https://www.eeoc.gov/eeoc/publications/fs-ada.cfm) . If you have difficulty using our online system due to a disability and need an accommodation, please email us at [email protected] or call us at 855-936-2666.

     

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