重庆招聘

Your Impact

As a Market Quality Specialist joining a newly acquired company you will play an integral role in ensuring implementation of quality systems in compliance with established standards and support local region. The individual will interact with local operating companies to ensure adherence to the ASP quality management system and local/in country regulations.

Here’s where you’ll demonstrate your competencies:

• Implements and supports ASP Quality Management System and its integrated programs within the respective region, such as document and records management, quality systems training, internal audits, nonconformances, corrective and preventive action, field actions, supplier quality management, procurement, servicing, distribution, and post market surveillance.
• Assures compliance with applicable regulations such as, but not limited to, FDA 21 CFR 820, ISO 13485, EU MD Directive/Regulations, Japan JPAL, NMPA, TFDA and Australian TGA.
• Supports quality oversight of local distribution and warehouse management process.
• Coordinates product return process with commercial team and monitors any physical product return to ensure proper control on physical product return to ASP facilities (including local 3PL warehouses and DC).
• Reviews and/or inspects returned products returned to 3PL warehouses, and coordinate the disposition of nonconforming products.
• Supports repacking/relabeling process.
• Assesses product quality issues and escalates to upper management through established processes.
• Supports timely post-market surveillance & vigilance (Field Actions and Product Complaints) management, such as product return, and complaint sample return to Manufacturing sites.
• Attend CAPA activities with regards to complaints, recalls, and other related non-conformances.
• Supports regional complaint leader to coordinate the product complaint follow-up.
• Supports regional complaint leader to manage adverse event reportability determination.
• Coordinates and contributes to customer response letters.
• Maintains quality records and adherence to records retention policies and procedures.
• Responsible for communicating business related issues or opportunities to next management level.
• Performs other duties assigned as needed.

Our Needs

Here’s what we’ll need from you:

• Bachelor’s degree or equivalent work experience
• At least 2 years of related experience in medical device or pharma regulated environment in the areas of Quality, R&D, Manufacturing, or related field.
• Demonstrated knowledge of regulatory standards and regulations, FDA 21 CFR 820, EU MD Directive/Regulations, Japan PAL, Canada CMDCAS, Brazilian ANVISA, NMPA, TFDA, and Australian TGA, ISO 13485, ISO 9001, ISO 14971.
• Training of medical device regulations to include ISO 13485 and 21 CFR 820 at minimum
• Ability to effectively negotiate and influence above, below and across the organization
• 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
• Must be able to work on multiplies priorities and tasks simultaneously, while acting in a decisive manner and demonstrating a bias for action
• High sense of urgency, adaptable to meet rapidly changing priorities
• Proven analytical/quantitative skills
• Project management skills, with the ability to drive change and influence decision making through multiple levels.

Preferred Skills:

• Six Sigma Process Excellence and/or Lean Excellence Green
  Belt trained
• ISO 13485 or ISO 9001 auditor qualifications

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。