job responsibilities:

lead the change control process for product changes, process changes, and documentation changes throughout their lifecycle.
evaluate change requests for completeness, accuracy, and compliance with regulatory requirements (e.g., us fda, ce, iso).
collaborate with cross-functional teams including research & development, regulatory affairs, quality assurance, manufacturing, and supply chain to assess the impact of proposed changes.
facilitate change review meetings and ensure timely resolution of issues and decisions.
develop and maintain change control procedures, templates, and forms.
ensure that changes are properly documented, including rationale, risk assessment, validation requirements, and verification activities.
provide guidance and training to employees on change control procedures and best practices.
lead and manage multiple projects concurrently throughout their lifecycle from initiation to closure.
develop and execute validation protocols and reports for equipment, processes, and systems used in the manufacture and testing of medical devices including sterilization.
conduct qualification studies for equipment and software, including installation qualification (iq), operational qualification (oq), and performance qualification (pq).
ensure that validation activities are conducted in accordance with fda regulations (e.g., 21 cfr part 820), iso standards (e.g., iso 13485), and other applicable regulatory requirements.
develop and maintain validation master plans, protocols, and validation summaries.
analyse validation data, prepare summary reports, and make recommendations for process improvements.

专业要求：不限

其他福利：双休,年度调薪,年度旅游，年终奖,中央空调办公环境

南京市高淳区经济开发区双高路86-8号

维克佳（南京）医疗器械有限公司，是英国公司vitalcare (uk) 的一家子公司，成立于2014年11月07日，注册资本250万美元，总投资500万美元。公司在高淳区经济开发区医疗器械产业园内，占地3202平方米，办公面积600平方米，生产车间全部都是净化车间，占地面积2050平方米，全自动生产线，配套全新的设备，环境优越。
公司主要生产ⅰ类、ⅱ类医疗器械；涵盖泌尿系统相关医疗产品的oem，如尿袋，尿套，导尿管及其辅材业务领域，为欧洲，美国和其他国际oem市场设计和制造泌尿类系统相关产品。
自2003年以来，公司总部 vitalcare（uk）一直处于欧洲oem市场泌尿系统类产品的设计和制造的最前前沿。公司秉承对产品质量和客户服务的高度重视，一直稳打稳扎，以确保公司产品、服务满足国际市场与客户所需，是中国领先的医疗产品制造商。