[上海]麦朗（上海）医疗器材贸易有限公司

职位：灭菌验证工程师 (MJ000108)
发布时间：2025-03-18
工作地点：上海
信息来源：前程无忧(51JOB)
职位类型：全职
职位描述
职能类别:医疗器械生产/质量管理
JOB SUMMAY:
- Prepare and execute sterilization related activities for medical device and pharmaceutical products.
- Support various Medline product divisions while assuring appropriate sterility assurance level to comply with FDA regulations and ISO standards.
- Provide technical consultant, support and troubleshoot sterilization processes and challenges across multiple modalities.


JOB RESPONSIBILITIES:
- Perform validation or revalidation independently to support management of sterile products in Asia, take on validation of new cycle, supplier owned validation and challenging projects under supervision. Manage conflicts, interact with suppliers and stakeholders, and communicate with internal team and cross-functional teams to push project development.
- Assign sterilization cycles to new products based on review of materials, product construction, and packaging. Review the validated process to confirm item sterilization.
- Review the sterilization documentations from sterilization facility against the latest sterilization agreement between Medline and the facility, and release the products for sterility purposes if all acceptance criteria for sterility release have been achieved. Issue, track and close CAPA, sterilization investigation, deviation or non-conformance reports when OOS happens.
- Be able to perform new supplier evaluation and disposition independently. Establish and maintain quality and steriliztaion processing agreement with sterilization facility.
- Perform vigilance audit and track corrective actions. Supervise and train supplier for performance of technical studies and routine control, make sure in compliance based on company procedure. Issue, track and close SCAR to supplier under supervision for major quality issues related to sterilization.
- Perform sterilization related supplier audit under supervision, track CAPA provided by supplier.
- Sterilization related database review and update.
- Other work assigned by line manager.


QUALIFICATIONS:
- Education level: Bachelor’s degree or above with science or engineering background. Microbiology background is a plus.
- Work experience: 2-5 years’ work experience in sterilization/packaging validation, or above 3-5 years’ work experience in manufacturing of medical device.
- Specific knowledge: Biological and chemical background is preferred.
- Certifications: ISO13485, ISO11135, ISO11137, ISO11607, ISO17665, or ISO17025 is preferred.
- Language: Fluent at both verbal and written English.
- Well known of sterilization and/or packaging related regulations and standards.
- Detail oriented with strong written and verbal communication, problem solving and follow up skills.
- Professional attitude with a heightened sense of urgency to complete tasks accurately and efficiently.
- Good multiple project management skills, have risk control consciousness
- Willing to travel with rate 30% to 60%.
- Proficiency of PC skills: MS Office Software, Statistical Software. 公司简要介绍：
公司名称:麦朗（上海）医疗器材贸易有限公司
公司类型:外资（欧美）
公司规模:150-500人
公司介绍:Medline公司于1966年正式成立，总部位于美国芝加哥，其历史可追溯到1910年由Medline创始人的祖父A.L.Mills所创立的西北制衣工厂。目前Medline已成为美国领先的私立国际性医疗用品制造商和卫生保健用品分销商，在全球拥有约30,000名员工，面向广大医疗机构与零售市场生产和销售医疗及外科产品，产品种类超过30万种。

Medline年销售额连续50多年持续增长，在医疗器械行业网站Medical Design & Outsourcing发布的2022年全球医疗器械公司百强榜中位列第五，2022年总销售额超过212亿美金。

麦朗（上海）医疗器材贸易有限公司作为Medline的全球采购中心，在亚太地区拥有500多名员工，在上海、武汉和越南设有多家法律实体。

Medline始终致力于为客户提供优质服务，践行改善医疗健康的使命，鼓励员工不断思考和创新，为客户和自身创造新的机遇，解决医疗健康领域所面临的挑战。

您可以点击 me***.cn[点击查看] 或在微信搜索“ 麦朗 Medline” 了解更多有关Medline的信息。