Work Flexibility: Onsite
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 (D0000001417) and NCR initiation when necessary.
协助 QE/SME 对超差 IMTE 进行处置，包括风险评估（D0000001417）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。
Travel Percentage: None