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Posted: Monday, March 13, 2017 12:01 AM

Integra LifeSciences, a world leader in medical technology, is dedicated to limiting uncertainty for surgeons, so they can concentrate on providing the best patient care. Integra offers innovative solutions in orthopedic extremity surgery, neurosurgery, reconstructive and general surgery, and regenerative wound care. Integras orthopedic products include devices and implants for foot and ankle, hand and wrist, shoulder and elbow, tendon and peripheral nerve protection and repair. Integra is a leader in neurosurgery, offering a broad portfolio of implants, devices, instruments and systems used in neurosurgery, neuromonitoring, neurotrauma, and related critical care. IntegraA?s Tissue Technologies is an in:patient and outpatient Regenerative product portfolio, which includes products for wound care, burns, abdominal reconstruction, and plastic and reconstructive surgery. In the United States, Integra is a leading provider of surgical instruments to hospitals, surgery centers and alternate care sites, including physician and dental offices. Founded in 1989 Integra is headquartered in Plainsboro, New Jersey and has over 3,300 employees worldwide. Integras common stock is listed on The NASDAQ Stock Market under the symbol IART.Quality Engineer will provide Quality and Compliance related support to the manufacture and distribution of medical devices in accordance with applicable medical standards and regulations (ISO 13485, 21 CFR 820, etc.). Technical support for and final review and approval of customer complaint investigationsSupport new product developmentEstablish and maintain Quality Management System proceduresFacilitate the execution of Risk Management activitiesIdentify statistically based sampling plans for inspections and validationsSupport validations for new and existing products, processes and equipmentEnsure compliance with cGMP, QSR, ISO13485, MDD, and other applicable regulations/standardsParticipate in FDA inspections, ISO Certification and surveillance audits and customer auditsIdentify and implement opportunities for continuous improvementInteract and coordinate activities with other departments, external vendors and customersAssist or lead in the identification and implementation of CAPAAid in the implementation SPC control system with Manufacturing and Quality ControlCompletes internal quality system auditsProvides support necessary for supplier controls, including but not limited to: supplier auditsParticipates in Post:Market Surveillance (PMS) activities as requiredCollection and reporting of metrics and data as requiredPerforms other Quality System related duties as required The requirements listed below are representative of the knowledge, skill and/or ability required for this position. Education: BS degree in Engineering, Science (Biology, Chemistry, Physics, etc.), or Math (Statistics)Certification: Certified Quality Auditor (ASQ CQA) or Certified Quality Engineer (ASQ CQE) would be a plus Experience: Minimum of two years of Quality Engineering experience in a manufacturing or industrial environment, preferably in an FDA regulated environmentKnowledge of statistical sampling and analysisKnowledge of ISO, FDA, and QSR concepts and guidelines as well as other national and international regulations and standardsAbility to read blueprints and interpret Geometric Dimensioning and Tolerancing (GD and T)Experience performing quality audits and utilizing manufacturing processes, techniques, and continuous improvement methodologies (i.e, Six Sigma, Lean Manufacturing, etc.).Knowledge of various MS Office applications such as: Word, Excel, and Powerpoint, including Microsoft Visio and ProjectExcellent organizational, written, and verbal communication skillsStrong interpersonal skills and ability to work with others in a positive and collaborative mannerStrong problem solving, leadership, and analytical skillsOutstanding attention to detailMust be able to observe company policies and safety procedures at all timesMust

Source: https://www.tiptopjob.com/jobs/64758917_job.asp?source=backpage


• Location: Cincinnati

• Post ID: 35212723 cincinnati
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