Details: Company Description Integra LifeSciences, a world leader in medical devices, is dedicated to limiting uncertainty for surgeons, so they can concentrate on providing the best patient care. Integra offers innovative solutions in orthopedics, neurosurgery, spine, reconstructive and general surgery.Integra's orthopedic products include devices and implants for spine, foot and ankle, hand and wrist, tendon and peripheral nerve protection and repair, and wound 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 is also 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 3,000 employees worldwide. For the last three years, Integra has been included in NJBIZ's list of "New Jersey's 50 Fastest Growing Companies." In 2010, we were also included in Forbes magazine's "America's 100 Best Small Companies".We value innovative thinkers who are open to new opportunities and derive satisfaction from knowing that their efforts are making a difference in someone’s life.Detailed Description The Product Development Quality Engineer Associate provides quality expertise in the design and development of new or significantly modified devices designed by Integra Extremity Reconstruction. The Product Development QE Associate is responsible for providing QA and Engineering leadership and technical support to assure that design and development activities are sufficient to meet the needs of customers and patients, and also meet applicable sections of FDA’s Quality System Regulations. The Product Development QE Associate will from time to time also be involved in general day to day quality assurance activities related to the quality of components, in-process, and finished devices at Integra Austin. Assures regulatory compliance in the area of verification and validation of the ER product development process. Contributes to and executes engineering schedules and plans. Prepares cost and time estimates for engineering and project schedules. Reviews and approves written reports and engineering documentation as necessary. Executes tactical implementation of strategic plans. Assures compliance with company Standard Operating Procedures and policies. Participates in team decision-making. Develops team problem solving and communication skills. Demonstrates knowledge and understanding of Good Manufacturing Practices and all other applicable standards. Stays informed about applicable new rules, regulations, and standards. Reviews and approves engineering test protocols for testing of component parts and integrated systems. Prepares verbal presentations for various company meetings. Maintains a clean, safe, and orderly work area. Follows all safety procedures. Performs other duties and responsibilities, as required. Works with RA/QA management and other RA/QA personnel to assure that software is developed and validated according to quality system requirements. Works with RA/QA management to support all areas of the business, as required. Works with all departmental personnel in the execution of engineering projects. Works with all functional departments to ensure proper management of interdepartmental projects. Works with engineering team members on team assignments and projects as necessary. Interacts with management on trouble shooting of production problems and changes as necessary. Interacts with management in the preparation of engineering change documents.
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