Skilled Calibrator

KEY RESPONSIBILITIES / DUTIES主要职责:

• Independently coordinate and execute calibration activities of IMTE with minimal supervision ensuring adherence to calibration intervals (QP00009-3).
  在最少监督下独立安排和执行 IMTE 校验任务确保符合校验周期QP00009-3
• Coordinate with internal team and external calibration suppliers; review and assess external calibration certificates for compliance (uncertainty raw data standards used).
  协调内部团队和外部校验供应商审核外部校准证书确认合规性测量不确定度原始数据所用标准等
• Perform advanced calibration tasks verification and documentation according to internal WI and regulatory requirements.
  按照内部作业指导书和法规要求执行更复杂的校准验证和文档记录
• Support disposition of out-of-spec IMTE in collaboration with QE / SME including risk evaluation (D) and NCR initiation when necessary.
  协助 QE/SME 对超差 IMTE 进行处置包括风险评估D及必要时发起 NCR
• Monitor IMTE usage frequency and wear trends; recommend calibration interval adjustment according to QP00009.
  监控 IMTE 使用频率和磨损趋势依据 QP00009提出校验周期调整建议
• Provide technical guidance and on-job training to Associate Technicians and operators regarding IMTE handling and calibration basics.
  为基础校验员和操作员提供技术指导与培训确保 IMTE 正确使用与合规校准
• Participate in production/inspection area audits ensure IMTE meets FDA / company calibration requirements and communicate non-conformances to responsible departments.
  参与生产/检验区域审核确保 IMTE 符合 FDA/公司要求并将不符合项反馈至责任部门
• Drive minor improvements on calibration processes and contribute to procedure optimization.
  推动校验流程的改进参与优化活动

• Other tasks assigned by Calibration Team Leader.

校验团队主管安排的其他职责

REQUIRED SKILL SET岗位技能

Skilled Calibrator熟练校验员

• Solid knowledge of calibration regulations standards and QP00009 procedure.
  精通校验法规标准及 QP00009 程序
• Ability to independently execute calibration and verify calibration data.
  能独立完成校准并核查校准数据
• Skilled in reviewing calibration certificates analyzing uncertainty and wear trends.
  能审核校准证书分析测量不确定度及磨损趋势
• Strong communication skills to coordinate with suppliers and internal teams.
  具备良好的沟通能力能协调供应商与内部团队
• Quality data analysis capability; basic understanding of GD&T.
  能进行质量数据分析具备 GD&T 基础
• Ability to provide training and guidance to junior staff.
  能为初级员工提供培训和指导