Senior Supplier Quality Engineer
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Job Location:
Monthly Salary:
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
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 4000 of us are challenging whats 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GMPFDA 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 candidates name resume or background) are position-specific and may only occur within the scope of that approved agreement. Please no phone calls or emails.
Required Experience:
Senior IC
Key Skills
- Quality Assurance
- Six Sigma
- Design Controls
- FDA Regulations
- ISO 9001
- Minitab
- Root cause Analysis
- ISO 13485
- Quality Systems
- Quality Management
- As9100
- Manufacturing
About Company
Integra LifeSciences, a world leader in medical technology with headquarters in Princeton, New Jersey, was founded in 1989 with the acquisition of an engineered collagen technology platform used to repair and regenerate tissue. Since then, Integra has expanded its base regenerative te ... View more
