Medline是最大的私人医疗用品制造商和分销商，其独特定位是为整个护理过程提供产品，教育和支持。我们将最佳实践从一个护理环境带到另一个护理环境的能力 - 从大型医疗保健系统和独立医生实践到家庭健康患者及其家人，是我们与众不同的原因。
我们的团队由临床医生，研究人员，工程师，金融专家和1200名具有出色专业知识的直销代表组成。他们从下到上依次了解医疗保健业务。
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Job Description
Be responsible for quality control of the products manufactured by the dedicated supplier factory/facility, responsibilities include but are not limited to process audits, CAPAs, deviations, calibrations, inspections, trainings, maintenance, environmental control, data collection and analysis, development of quality related methodology, etc.
Ensure the supplier is clear on Medline and International quality standards, processes and procedures for medical device manufacturing.
Work with the supplier to implement and maintain sufficient GMP and quality systems such as good documentation practices, purchasing control, internal audits, etc.
Perform and/or instruct in-line and finished good inspection and testing in accordance with Medline and International Standard to ensure acceptable quality.
Work with Medline Shanghai and US team to determine appropriate testing parameters for the products to ensure limited failures in the field.
Work closely with suppliers, the Shanghai office and the corporate office in the USA to lead product changes and improvements.
Lead the root cause investigations and analysis for quality issues such as customer complaints and inspection rejections. Implement CAPAs based on root cause investigations to reduce complaint numbers. Ensure that solutions to quality issues are properly implemented and upheld.
Work with supplier to validate and optimize the production parameters and ensure the supplier properly document and verify these parameters once implemented.
Identify opportunities and implement activities for continuous improvement in process stability and product quality, activities include but are not limited to the appropriate goal settings and bonus formulation, application of quality tools such as data trending analysis, etc.
Cooperate with multiple departments such as purchasing, warehouse, logistics, HR to ensure the factory/facility is operated under satisfied conditions and meeting business prospects.
Qualifications:
B.S. Degree in Mechanical Engineering, Industrial Engineering, Manufacturing Engineering, Automation, or other related science and engineering fields required.
Fluent in English is a must. Japanese is a plus.
5+ years of experience in process control and quality control is required, process audit skills and quality system audition skills in medical device industries will be highly preferable.
Detail oriented with strong written and verbal communication, problem solving, and organizational skills.
Professional attitude with a heightened sense of urgency to complete tasks accurately and efficiently.
Ability to effectively recognize and suggest improvements for finished products, processes and documentation practices to suppliers, managers, and coworkers.
Proficiency of PC skills: MS Word, MS Excel, Adobe and E-mail, AutoCAD or SolidWorks is a plus.
