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 Senior Quality Engineer position is one of creation and innovation, which leads to the development and introduction of product quality. The Senior Quality Engineer is responsible for: a) product quality through proper design and implementation of appropriate procedures and specifications; b) raw materials quality including purchasing quality materials from an approved and qualified supplier base and to appropriate specifications; c) finished goods quality. Reviews raw material, in process and finished product specifications for proper design and requirements. Supports product development activities for new Surgical Headlamp systesms as department Design Assurance representative. Directs staff of QC Inspectors in execution of daily responsibilities for inspection of incoming materials and finished devices for tissue ablation, brain mapping and surgical headlamp systems. Develops Inspection procedures and identifies/procures proper test/inspection equipment to assure raw material, in process and finished product quality. Maintains/selects Integra supplier base through surveys, audits, process capability studies and ongoing interface and reporting. Performs supplier corrective actions as required per procedures. Supports new product development teams to assure product quality is achieved through proper design, testing and Engineering and Quality specifications. Addresses defect prevention through review of quality history, supplier base controls, scrap analysis, process control techniques and training. Supports Integra production to resolve/identify products relative to purchased raw material. Conducts timely investigations on suspect products returned to Integra through the Complaint process. Reviews/develops Engineering test/qualification protocols where required to assure product/design changes are properly validated prior to release. Acts as the Technical Specialist to Purchasing in supplier-related quality issues. Supports the Inspection group on inspection/training/equipment related issues. Communicates and carries Quality Engineering philosophy to other groups within Integra. Supports MRB activities through review of rejects and disposition of materials. Supports process validation activities at Integra. Assures compliance of Integra SOPs. Reviews Engineering Change Orders, as required. Performs process capability analysis and assists in design of experiment activities. Performs other duties and responsibilities, as required. Assists Purchasing on supplier-related issues and supplier selection and control. Assists Inspection personnel in the performance of their assigned responsibilities. Interfaces with Product and R&D Engineering on design and specification related issues as well as Integra tool approvals, as required. Interfaces/supports Manufacturing. Works closely with QARA personnel to assure compliance with Quality Systems requirements
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