Senior Quality Engineer II

Job description

Changing lives. Building Careers. Joining us is a chance for you to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, more than 4,000 of us are challenging what’s possible and making headway to help improve outcomes. Under general supervision, direction, and in accordance with all applicable federal, state and local laws/regulations and Corporate Integra Lifesciences procedures and guidelines, this position: Reviews new and modified product design and manufacturing processes for quality characteristics, including manufacturability, serviceability, testability, reliability and conformance to product and quality system requirements. Manages the product risk management process, including the development and maintenance of risk management files. Qualifies component and service suppliers, conducts supplier audits and ensures that appropriate supplier quality controls are implemented. Analyzes data and applies knowledge of engineering principles and practices to implement continuous improvement projects. Monitors internal and external standards changes related to quality engineering requirements and develops and implements compliance strategies. Provides guidance to R&D, Operations and Quality on design and production/process controls, risk management, root cause analysis, validation, and the application of statistical methods. Interact closely with software, mechanical, systems, and electrical engineering disciplines to develop comprehensive solutions to design problems. Provide high-level technical assessments and communications to functional leadership Other responsibilities as required or assigned by manager. EXPERIENCE AND EDUCATION Required: Bachelor's degree in a life science, engineering, physical science or related discipline At least 8 years of experience as a Quality Professional in an FDA-regulated industry, with at least 5 years in the Medical Device industry In-depth knowledge of design control, risk management, production and process controls and applicable regulations (i.e., ISO 13485, FDA Quality System Regulation, ISO 14971) Working knowledge of and experience in the application of statistical methods Superior verbal and written communication skills and the ability to effectively communicate with internal and external personnel at all levels of the organization Preferred: Advanced degree in a life science, engineering, physical science, or related discipline Process Excellence/Six Sigma certification ASQ Certified Quality Engineer (CQE) This role will be based in Haifa following our planned office relocation in 2026. Unsolicited Agency Submission Integra LifeSciences does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. A formal written agreement is required before engaging any agency, and it must be executed and authorized by the Vice President, Talent Acquisition. Where agency agreements are in place, introductions (the initial sharing of a candidate’s name, resume, or background) are position-specific and may only occur within the scope of that approved agreement. Please, no phone calls or emails.