南京招聘

Responsibilities:

1. Work independently, establish an efficient and engaged QA team and lead the oversea training efforts

2. Establish and maintain the effectiveness of Quality Systems to assure Compliance with ISO13485-2003 (or QSR 820), and CFDA policies.

3. Manage the routine quality operation for incoming, in process and final inspections, including microbiology verification

4. Manage the regulatory affair activities by developing and implementing the certification plan, include manufacturing license, product registration, export certification and others, and maintain positive relationship with relevant administrative bureau, such as SFDA.

5. Establish and maintain Standard Operating Procedures, work instructions, forms, templates and other documents associated with the systems noted above

6. Work collaboratively with the production and sterilization Dept. and other functions to assure Compliance.

7. Work collaboratively with required functions as part of a cross functional team to ensure continuous improvement

8. Assists in the development of training programs as required to support the implementation and maintenance of quality systems

9. Work with engineering and sourcing department of new material, equipment and process development, improve supplier quality performance via Quality Plan implementation

10. Interface with Suppliers, Tech Ops, Technical Services and Supply Chain Sourcing to drive Quality improvements that minimize the Costs of Quality, specifically component, materials or finished product deviations.

11. Provides reports and trends to the Management Representative to help in the preparation of Management reviews and/or other ad hoc reporting requests

12. Conducts audits of suppliers to ensure compliance with NMH requirements as well as applicable regulatory requirements

13. Assure Corrective and Preventive Action plans are developed and executed at assigned suppliers in compliance with the CAPA process

14. Interfaces with project teams to assure that the goals set by the team as they relate to potential suppliers are consistent with BVI quality objectives and relevant governmental requirements

Knowledge and experience:
1. Bachelor's degree in Chemistry, Engineering or other Physical Sciences
2. Minimum 3 years of Quality management experience specifically in medical device with a total of 5 years of combined manufacturing QA or QC assurance roles
3. With knowledge of 13485 Medical Devices requirements and clean room management
4. With experience of new medical product registration and licensing
5. With knowledge of ISO11135-EO Sterilization requirements for validation, and routine control - radiation sterilization, will be a plus.
6. Supplier QA experience (managing/auditing of suppliers) in the medical device or pharmaceutical industry
7. Experience in internal/external auditing, Ability to handle supplier audit situations and interactions in a tactful, professional and effective manner
8. Communication skills (both written and orally) with external and internal customers
9. Good command of English (written and spoken), this is a must.
10. User level knowledge of computers and software
11. Be proactive, quick learner, initiative and work well under pressure

    南京易乐医疗器械有限公司总部位于南京市***江北新区智能制造产业园内，专业从事医疗器械销售及服务，其具体涵盖：眼科、神经外科、介入科、ICU重症监护、内分泌科产品等一次性医用耗材，以及mNGS二代基因测序和肿瘤检测服务。
公司秉承“用户***，顾客至上”的经营理念，作为中国总代理推广BVI倍锋的全系列产品、UltraPlug泪点塞栓、华熙生物眼用粘弹剂。并作为美国BD、美敦力、德国贝朗、明基新材料、上海微创、微远基因等知名品牌的一级代理商。在全国范围内与合作伙伴一起建立了完善的销售网络，所代理产品近年在细分领域的市场占有率名列前茅，公司业绩持续大幅增长，2019年被评为“南京市瞪羚企业”。
自成立以来公司积极投身公益事业，与爱尔眼科、普瑞眼科集团、天津眼科医院、浙医二院等业内领先的医疗机构合作开展形式多样的慈善活动。作为江苏侨联创新创业联盟理事单位，公司同时注重制度和文化建设，建立了一整套科学的管理体系，拥有大批高素质人才，其中多人具有临床医学、质量检验等方面背景，为公司的品牌战略和产品推广提供了有力的保障。