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Group Lead, Quality Control

Location Cincinnati, United States
Posted 11-November-2019
Description
Job Description:

Overview 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. Integra's 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. Integra's Tissue Technologies is an in-patient and outpatient Regenerative product portfolio, which includes products for wound care, burns, abdominal reconstruction, and plastic & 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 4,500 employees worldwide. Integra's common stock is listed on The NASDAQ Stock Market under the symbol 'IART.' Responsibilities SUMMARY DESCRIPTION The QC Group Leader has primary responsibility to lead all shifts, in the day-to-day execution of receiving inspection requirements to meet quality, compliance and production needs. RESPONSIBILITIES. Supervises the quality control team to build, maintain, and cross train an effective workforce within the receiving inspection operation.. Prioritizes the completion of quality inspection tasks to meet production deadlines.. Assist with Control of Nonconforming Product process activities (eg, product quarantine).. Support Measurement/Test Methods Validations as needed.. Supports internal and external audit/inspection activities. Qualifications. Associates degree in Engineering or Quality, or 3-5 years of working experience in Quality Assurance/Control.. Minimum of two years' experience in a regulated industry, preferably Medical Device Industry. Knowledge of medical device regulations (including FDA QSRs, ISO13485).. Ability to use a wide assortment of QC inspection, measuring, and test equipment (calipers, gauges, micrometers and optical comparator) to assure components and devices are manufactured and functioning according to specification.. Excellent mathematical skills (tolerance analysis, sampling plans).. Ability to read blueprints; GD&T skills preferred.. Technical aptitude (ie able to read and comprehend technical documentation, ability to comprehend and execute procedures, demonstrated understanding of system documentation).. Experience with CAPA processes (eg, nonconforming product, product holds).. Quality certification (CSSGB, CMI, CQE, CQT or CQA preferred but not required). Ability to effectively communicate to all levels of management within the organization.. Ability to communicate effectively (both written and oral) using English (or local language).. Familiar with the MS Office Suite, including Microsoft Visio and Project. Must be able to observe company policies and safety procedures at all times.. Demonstrated ability to work cross-functionally in a team environment.. Must be able to treat others with respect; work with integrity and ethically; uphold organizational values.

 
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