Senior Quality Assurance Specialist

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.

• •    Ensures that adequate Quality support is provided to productions and to open projects / initiatives
  确保为生产和项目/计划提供足够的质量支持 

  •    Ensures that Nonconformances are initiated, dispositioned, approved and investigated according to plans and in compliance with procedures and regulatory requirements
  确保不符合按照计划、程序和法规要求进行启动、处理、调查和批准

  •    Ensures that quality activities for validation of new processes/ products are performed and documented according to procedures and within the defined timeline
  确保新工艺/产品验证的质量活动按照程序并在规定的时间内进行并记录

  •    Write protocols and reports for validation documentation (such as process validation, test method validation, validation plan.)
  编写验证文档的方案和报告(如工艺验证，测试方法验证，验证计划等) 

  •    Ensures that risk analysis activities (PFMEA) are performed and documented according to procedures and within the defined timeline
  确保风险分析活动(PFMEA)在规定的时间内按照程序进行并记录 

  •    Organize meeting for risk analysis activities and write risk management documentation
  组织风险分析会议，撰写风险管理文件

  •    Ensures that GMP rules are known, understood, and respected on the site
  确保GMP规则在现场被了解、理解和遵守

  •    Ensure technical support to QC and laboratory department
  确保QC和实验室部门的技术支持

  •    Collaborate with supplier quality team, manage supplier, ensure suppliers are qualified based on procedures to meet regulation requirements.
  和供应商质量团队合作，管理供应商，确保供应商被评估和审核，满足法规要求 

  •    Escalates quality issues and makes sure that appropriate actions are in place to fix the issue in a compliant manner
  升级质量问题，并确保采取适当的措施以合规的方式解决问题

  •    Participates and supports internal and third-party audits / inspections
  参与并支持内部和第三方审核/检查

  •    Manages or participates to quality projects
  管理或参与质量项目 

  •    Provides support to complaint investigation
  为投诉调查提供支持

  •    Establish product related quality system documents, participate to procedure elaboration or update
  建立和产品相关的体系文件，参与流程的细化或更新

  •    Establish testing method for products, ensure applicable gages or equipment for products testing, train inspectors and ensure inspectors can understand the testing method.
  建立产品的测试方法，确保产品检测有合适的量具和设备，对检验员进行培训，确保检验员能掌握测试方法

  •    Ensure that the release of raw materials and semi-finished products complies with procedures and regulatory requirement
  确保原材料和半成品的放行符合程序和法规要求

  •    Ensure that the release of finished products complies with the requirements of procedures and regulations
  确保成品的放行符合程序和法规的要求

  •    Ensures that CAPA are managed and documented according to plans and in compliance with procedures
  确保CAPA按照计划和程序进行管理和记录

  •    Ensure all quality system related change are initiated, evaluated, and ensure all actions of change control are followed up closely and closed in time.
  确保影响质量体系的相关变更能按照文件要求发起，评估，并确保变更相关的活动可以及时完成

  •    Ensures support to process improvement projects
  确保对工艺改进项目的支持

  •    Arrange the daily work of the inspectors, provide necessary training, ensure that the inspectors meet the qualification requirements for their positions. Complete other tasks assigned by the supervisor.
  安排检验员日常工作，提供必要的培训，确保检验员符合岗位资质要求。完成主管安排的其他任务。
   

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.