Supv, Quality Control

embecta is a global medical device company with a 100-year legacy in insulin delivery and diabetes care. Driven by innovation, purpose, and a commitment to improving lives, we are expanding our portfolio of solutions to serve even more patients, healthcare providers, and communities around the world.

主要职责KEY RESPONSIBILITIES:

1.     负责检验员团队的人员管理并根据生产计划安排检验工作；
Responsible for the quality inspectors team management and arrange inspection work according to the production plan;

2.     负责建立检验员团队的人员操作技能培训及发展计划，并监督实施和跟踪管理，以及人员的绩效管理；
Responsible for establishing the training and development plan for the inspector team, and supervising the implementation and follow-up Control Budget and expense, as well as performance management of inspectors;

3.     主动处理绩效问题与冲突；运用判断力协同部门领导和人力资源部门开展工作。负责团队在培训方面的合规性、任务目标的完成、新员工入职引导以及现有团队发展;

Managing performance issues and conflict proactively; uses judgement in consulting with department leadership and Human Resources. Responsibility for the team´s compliance in terms of training, and fulfilment of their tasks and objectives as well as onboarding of new employees and development of the existing team;

4.     负责生产线相关质量记录的收集、整理和存档，以及数据分析;
Be Responsible for collection, collation and archiving of related quality records for production line, as well as data analysis;

5.     负责质量管控工作，包括制定或者更新质量文件、建立并维护产品检验方法，完成或审核检验方法验证包括验证计划方案、验证报告和偏差分析报告的审核;
Responsible for QA activities, including establish/update quality procedures, establish and maintain inspection method, initiate or review  test method validation ,including validation plan protocol, report and deviations;

6.     主导和支持生产过程中的潜在产品质量问题的调查和处理;

Lead and support the investigation and handling of potential quality event;

7.     负责组织对原材料、生产过程中发生的不合格和偏差的原因调查及不合格品处置，参与制定纠正预防措施及并跟踪措施的落实直至NCR关闭;
Responsible for NCR and plant deviation investigation, corrective action implementation, actions tracking till NCR close;

8.     作为质量成员，主导和支持相关质量改善项目；参与日常质量巡检并能识别潜在质量体系风险进行及时纠正;

Lead and support relevant quality improvement project from quality function. Participate in regular quality inspections with ability to identify and correct potential quality system risks;

9.     其他可能分配到的工作。

Other assignments per needs.

embecta is an Equal Opportunity/Affirmative Action Employer.  We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.