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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 協助法規事務經理制定、實施和維護有效的質量管理體系，以符合醫療器械適用法規 (如:醫療器械生產質量管理規范、美國聯邦法規食品藥品監督管理局-21條 質量體系法規等)和適用標準(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 評審過程和軟件確認及驗證活動，以符合上述法規和適用標準
Review the process and software validation activities to ensure the validation processes fully comply the above requirements.
61 協助法規事務經理管理質量管理體系文件，組織管理評審會議和準備相關材料。
Assist MRA Manager to manage quality management system documents, organize management review meeting and prepare related data and files.
61 作為審核協調員，根據醫療器械適用法規標準的要求，計劃和協調質量管理體系內部審核活動。
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 作為糾正預防措施工程師/協調員，確保糾正預防措施有效實施、評價和監督以及及時關閉。
Act as CAPA engineer/coordinator to ensure to implement, evaluate and monitor corrective actions and preventive actions effectively and close in time manner.
61 協助法規事務經理協調配合監管機構以及第三方審核機構的審核或檢查，參與并支持客戶審核活動。
Assist MRA Manager to coordinate the audit or inspection from third-party notify body and regulatory authorities and support customer audit activities.
61 上級安排的其他工作。
The other works assigned by superior.
The experience we’re looking to add to our team:
61 大學專科或專科以上
College or above
61 3年以上醫療器械行業質量工程或質量管理體系相關工作經驗。
3 years or above working experience in quality engineering or quality management system for medical device.
61 有PCBA和電子產品組裝過程的相關工作經驗。
Be experienced in PCBA and electronics product assembly process.
61 有醫療驗證經驗的優先考慮
Medical Validation experience is preferred.
61 熟悉醫療質量管理體系（如YY/T0287/ISO13485）以及醫療器械相關法規（醫療器械監督管理條例、醫療器械生產質量管理規范）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 具備理解和實施內部審核的知識和能力。
Knowledge and ability to understand and implement internal audits of QMS.
61 良好的溝通、表達、人際關系和組織能力。
Good skills of communication, presentation, interpersonal relationships and organization.
61 積極主動、獨立工作的能力和良好的團隊合作精神。
Initiative, independent and good team player.
What you’ll receive for the great work you provide:
61 Social Insurance
61 Life Insurance
61 PTO