青岛招聘

Work Type: Hybrid
This position ensures development and implementation of quality systems in
compliance with established standards and support local region. The individual
will interact with and provide oversight to local operating companies to ensure
adherence to the ASP quality management system and local/in country regulations.

Duties and Responsibilities

* Implements and supports ASP Quality Management System and its integrated
programs within the respective region, such as quality systems training,
internal audits, nonconformances, corrective and preventive action, records
management, field actions, supplier quality management, procurement, servicing,
distribution, and post market surveillance.
* Assures compliance with applicable regulations such as, but not limited to,
ISO 13485, EU MD Directive/Regulations, China GSP & GMP.
* Maintains, sustains and continuously improves the Quality Management System
and monitors the performance and health of the Quality Management System
through metrics and analytics.
* Oversees quality operations activities performed by contract manufacturer
under MAH regulations.
* Maintains quality oversight of local distribution and warehouse management
process (assessment, qualification, monitoring).
* Perform commercial release of China made medical devices.
* Supports local supplier/vendor selection, qualification, and audits.
* Ensures timely investigation of nonconformances.
* Establish corrective and preventive actions to mitigate potential or actual
noncompliance risks.
* Assesses product quality issues and escalates to upper management through
established processes.
* Ensures timely post-market surveillance & vigilance (Field Actions and
Product Complaints) management
* Ensures timely and consistent escalation of events.
* Support market quality compliance activities as required by the direct
manager and in collaboration with associates.
* Collaborate cross-functionally to support projects assigned by the direct
manager.Qualifications

* Bachelor’s Degree or above
* Minimum of 5 years of experience in medical device industry in the areas of
Quality, Manufacturing, or related field.
* Demonstrated knowledge of regulatory standards and regulations, such as,
but not limited to, China GSP & GMP, MAH regulations, ISO 13485, ISO 14971.
* Ability to work and communicate in a cross-cultural environment
* Excellent communication skills both written and verbal
* Highly developed influence, interpersonal, communication and conflict
resolution skills
* Ability to interact with all levels and disciplines within the organization
* High sense of urgency, adaptable to meet rapidly changing priorities
* Proven analytical/quantitative skills

ASP是全球领先创新灭菌和消毒解决方案供应商，总部位于美国加利福尼亚州欧文市，在世界各地设有多个办事处。 ASP支持医疗机构保护患者免受医源性感染的影响，其解决方案包括提供设备、耗材和软件，用于可重复使用手术器械的低温终端灭菌和高水平消毒。加入我们，共同为患者及其家人、医疗工作者以及社区生活创造安心的环境。