Integra LifeSciences Jobs

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.

• A minimum of a Bachelors Degree is required, preferable in Engineering, a Life Science or a related technical discipline.

• 4-7 years Experience working in a Medical Device manufacturing environment is preferred.

• Fluent in Chinese and English

• Knowledge of Medical device standards and regulations, such as China GMP, ISO13485, 93/42 EEC, 21 CFR part 820

• Good communication, organizational, negotiation and interpersonal skills

• Good analytical problem solving skills.

• Use of Agile, Oracle, EtQ, Minitab

• Use of Microsoft office tools

• Good knowledge of statistical techniques

本科以上学历，工科、生命科学或相关专业优先。

4-7年医疗器械制造工作经验优先。

•中英文流利

了解医疗器械标准和法规，如中国GMP, ISO13485, 93/42 EEC, 21 CFR part 820

良好的沟通、组织、谈判和人际交往能力

良好的分析和解决问题的能力。

•使用Agile, Oracle, EtQ, Minitab

•使用微软办公工具

良好的统计技术知识

• Ensures that adequate Quality support is provided to productions and to open projects / initiatives

• Ensures that Nonconformances are initiated, dispositioned, approved and investigated according to plans and in compliance with procedures and regulatory requirements

• Ensures that quality activities for validation of new processes/ products are performed and documented according to procedures and within the defined timeline

• Write protocols and reports for validation documentation (such as process validation, test method validation, validation plan..)

• Ensures that risk analysis activities (PFMEA) are performed and documented according to procedures and within the defined timeline

• Organize meeting for risk analysis activities and write risk management documentation

• Ensures that GMP rules are known, understood and respected on the site

• Ensure technical support to QC and laboratory department

• Escalates quality issues and makes sure that appropriate actions are in place to fix the issue in a compliant manner

• Participates and supports internal and third party audits / inspections

• Manages or participates to quality projects

• Provides support to complaint investigation if required

• Establish product related quality system documents, participate to procedure elaboration or update

• Establish testing method for products, ensure applicable gages or equipments for products testing, train inspectors and ensure inspectors can understand the testing method.

• Ensures that CAPA are managed and documented according to plans and in compliance with procedures

• Ensure all quality system related change are initiated, evaluated, and ensure all actions of change control are followed up closely and closed in time.

• Ensures support to process improvement projects

确保为生产和项目/计划提供足够的质量支持

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

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

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)

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

组织风险分析会议，撰写风险管理文件

确保GMP规则在现场被了解、理解和遵守

确保QC和实验室部门的技术支持

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

参与并支持内部和第三方审核/检查

管理或参与质量项目

如有需要，为投诉调查提供支持

建立和产品相关的体系文件，参与流程的细化或更新

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

确保CAPA按照计划和程序进行管理和记录

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

确保对工艺改进项目的支持