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 3,300 employees worldwide. Integra's common stock is listed on The NASDAQ Stock Market under the symbol "IART." Responsibilities Perform assigned complaints investigations, including but not limited to Product Failure Analysis and complaint documentation review (DHR, complaints history, products instructions, risk management, etc.) and investigation reports. Prepare weekly and monthly metrics for Quality Management Reviews and Operational Reviews such as trend charts, Pareto Analysis, etc., as required. Quality Problem Resolution by means of Root Cause/Problem Solving Analysis. Implementation of corrective and preventive actions as result of complaint investigations, as required. Support to FDA inspections, ISO Certification and surveillance/customer audits, as required. Interact with PD, QA, Clinical Affairs and Technical Support personnel at Corporate and Division level. Issue or update of manufacturing/quality documents (i.e. Shop Orders, Specifications, Drawings, Inspection Criteria, SOP, etc.), as required. Update of internal Complaint tracking system. Coordinate and conduct Complaint Review Boards. Complete assigned Non-Conformance and/or CAPA investigations, as required. Maintains traceability of items in plant to determine current status or access information required to support management decision making or provide information requested by other personnel. Communicates with corporate office to attend details related to complaints (e.g. additional info). Perform other related duties as required. Qualifications Bachelor degree in Science or Engineering. One (1) to Three (3) years of experience in manufacturing environment, within the FDA regulated industry, with exposure to production documentation and Quality Assurance/Regulatory functions or equivalent experience in a similar position. Experience in Medical Devices, preferable. Knowledge of FDA 21CFR 820, ISO-13483:2003, CMDR, MDD (93/42/EEC), TGA, PAL and other National and International regulatory requirements. Experience in working on teams. Knowledge of regulated manufacturing processes, GMP's, and FDA – QSR, Canadian and ISO regulations and standards. Possess strong analytical, exceptional writing, and interpersonal relationship skills. Written and verbal effective communication skills in Spanish and English. Strong leadership skills and the ability to deal effectively and persuasively with all levels of management. Capable of managing multiple priorities and meet closely spaced, ambitious timelines. Rapidly adapt to changing environment and circumstances requiring flexibility, tolerance and great sense of urgency while ensuring that all GMP and Regulatory requirements are met. Competent in the use of computer programs (Word, Excel, etc.) SDL2017
