Senior Supplier Quality Engineer

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. stablishes and ensures the Approved Supplier List is up to date 建立并确保最新的《批准的供应商清单》 • Establishes timely planning and execution of supplier audits 及时规划和执行供应商审核 • Conducts Supplier Audits according to good manufacturing practices, ISO Standards, and applicable regulatory requirements 根据良好生产规范、ISO 标准和适用的法规要求进行供应商审核 • Ensures comprehensive measurement systems in place to monitor supplier quality/reliability, and to identify, correct and prevent defects 确保建立全面的测量系统，以监控供应商的质量/可靠性，并识别、纠正和预防缺陷 • Establish and ensure Supplier Quality Agreements are up to date for applicable suppliers engaged in the production of Integra products 为从事英特格拉产品生产的适用供应商建立并确保最新的《供应商质量协议》 • Ensure technical support to QC, purchasing and production etc. departments 确保对QC、采购和生产等部门的技术支持 • Provide Quality Support to suppliers including audits/assessments, inspection technique support, verification /validation activities, CAPA and change management. China GMP, FDA CFR part 820 and ISO 13485 regulations/standards will be the focus. 为供应商提供质量支持，包括审核/评估、检验技术支持、验证/确认活动、CAPA 和变更管理。中国GMP、FDA CFR 第 820 部分和 ISO 13485 法规/标准将是重点。 • Addresses Supplier Change Requests in compliance with procedures and regulatory requirements. 根据程序和法规要求处理供应商变更请求。 • Ensures that activities for validation of outsourced processes/products are performed and documented according to procedures and within the defined timeline. 确保外包过程/产品验证活动按照程序并在规定的时间内执行和记录。 • Ensures that Supplier Non-conformances are initiated, dispositioned, approved and investigated according to plans and in compliance with procedures and regulatory requirements. 确保根据计划并遵守程序和法规启动、处置、批准和调查供应商不合格项要求。 • Escalate supplier quality issues to management as appropriate, develop and propose robust and compliant solutions. 需要时将供应商质量问题上报管理层，制定并提出稳健且合规的解决方案。 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. Changing Lives. Building Careers. 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 neurosurgery, reconstructive and general surgery, and regenerative wound care. Founded in 1989 Integra is headquartered in Princeton, New Jersey and has more than 4,000 employees worldwide. Integra’s common stock is listed on The NASDAQ Stock Market under the symbol “IART.”