南京招聘

【质量验证工程师 - 灭菌】

美国医疗耗材公司因业务需要新招职位

工作地点：全国范围都可以考虑，上海or武汉是office办公，全国其余城市homebase

要求：

1. 医疗器械，制药等有无菌要求行业背景，负责灭菌确认，灭菌审核，微生物，实验室的候选人都可以考虑

2. 能接受50%以上全国及东南亚国家出差

3. 英文口语可以沟通。

1 Work as project manager for validation/qualifications in order to approve purchasing sterile medical products from suppliers/manufacturers in Asia

2 Prepare study protocol and report in English

3 Supervise and train plant personnel for performance of technical studies and procedures

4 Write technical agreements with suppliers

5 Perform technical and regulatory audits of sterilization facilities and medical device manufacturers.

6 Intensive travels to vendors for quality check and ensure suppliers meeting quality requirements

Requirements:

1 Bachelor or above, major in Biotechnology, Pharmaceutical, Chemical or Engineering

2 5 years of work experience in quality/technical department of health care related company. Experience in validation/qualification activity is an advantage.

3 Knowledge of GMP regulation, AAMI and ISO standards and validation methods is preferred.

4 Microsoft Word and Excel experience at an intermediate level is required

5 Good oral and written English

6 Willing to travel intensively

7 Project management skill is a plus

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