To support our extraordinary teams who build great products and contribute to our growth, we’re looking to add a MRA Engineer located in Suzhou Suqian.
Reporting to the MRA Manager the MRA Engineer role involves…
What a typical day looks like:
61 协助法规事务经理制定、实施和维护有效的质量管理体系，以符合医疗器械适用法规 (如:医疗器械生产质量管理规范、美国联邦法规食品药品监督管理局-21条 质量体系法规等)和适用标准(如:YY/T0287/ ISO13485)要求。
Assist MRA Manager to develop, implement and maintain an effective quality management system to comply with applicable regulations for medical device (e.g., Good Manufacturing Practice for Medical Devices, 21 CFR Part 820, etc.) and applicable standards (e.g., YY/T0287/ ISO13485).
61 评审过程和软件确认及验证活动，以符合上述法规和适用标准
Review the process and software validation activities to ensure the validation processes fully comply the above requirements.
61 协助法规事务经理管理质量管理体系文件，组织管理评审会议和准备相关材料。
Assist MRA Manager to manage quality management system documents, organize management review meeting and prepare related data and files.
61 作为审核协调员，根据医疗器械适用法规标准的要求，计划和协调质量管理体系内部审核活动。
Act as internal audit coordinator need to plan and coordinate QMS internal audit activities in accordance with available regulations and standards for medical devices.
61 作为纠正预防措施工程师/协调员，确保纠正预防措施有效实施、评价和监督以及及时关闭。
Act as CAPA engineer/coordinator to ensure to implement, evaluate and monitor corrective actions and preventive actions effectively and close in time manner.
61 协助法规事务经理协调配合监管机构以及第三方审核机构的审核或检查，参与并支持客户审核活动。
Assist MRA Manager to coordinate the audit or inspection from third-party notify body and regulatory authorities and support customer audit activities.
61 上级安排的其他工作。
The other works assigned by superior.
The experience we’re looking to add to our team:
61 大学专科或专科以上
College or above
61 3年以上医疗器械行业质量工程或质量管理体系相关工作经验。
3 years or above working experience in quality engineering or quality management system for medical device.
61 有PCBA和电子产品组装过程的相关工作经验。
Be experienced in PCBA and electronics product assembly process.
61 有医疗验证经验的优先考虑
Medical Validation experience is preferred.
61 熟悉医疗质量管理体系（如YY/T0287/ISO13485）以及医疗器械相关法规（医疗器械监督管理条例、医疗器械生产质量管理规范）的要求。
Familiar with the requirements of medical quality management system (such as YY/T0287/ ISO13485) and relevant regulations on medical devices (Regulations on supervision and Administration of Medical Devices.
61 具备理解和实施内部审核的知识和能力。
Knowledge and ability to understand and implement internal audits of QMS.
61 良好的沟通、表达、人际关系和组织能力。
Good skills of communication, presentation, interpersonal relationships and organization.
61 积极主动、独立工作的能力和良好的团队合作精神。
Initiative, independent and good team player.
What you’ll receive for the great work you provide:
61 Social Insurance
61 Life Insurance
61 PTO