苏州招聘

Please be noted that this position is recruited by Medline's vendors. Our supplier is a manufactory which has 500 employees above. The products are Medical device. Mainly products are sold in US.

Role Summary/Purpose:
The QA manager will oversee quality systems, processes, and procedures to assure product safety and quality, as well as Quality Management Systems and regulatory compliance to FDA's QSR and ISO13485 at facilities.
Job Responsibilities
1. Accountable for implementation of the Quality Management System at the site.
2. Responsible for engaging strong intradepartmental and cross-functional/organizational relationships to drive Quality Management System implementation.
3. Ensuring training programs are current and employees are trained in accordance with latest regulatory requirements across the company.
4. Provide leadership and coaching for the quality Control team.
5. Ensure the timeliness testing of our products manufactured in just-in-time process.
6. Coach the quality Control team on the tools and practices required to drive day-to-day processes.
7. Participate and lead qualification and validation of Quality Control equipment/ processes
8. Initiate improvements in the quality across the production processes
9. Participate in the plant-wide effort to reduce scrap and rework costs, and to identify root causes and solutions for quality defects.
10. Ensure the meaningful and timely resolution of CAPA's, non-conformances, complaints and change controls.

Qualifications/Requirements
1. Bachelor's Degree in Science or in Engineering or related field
2. Minimum of 4 years experience in supervisory and managerial experience.
3. Minimum of 5 years experience working in a regulated medical device or pharmaceutical environment, quality control/assurance, or regulatory assurance
4. Knowledge in quality system regulations (QSR etc.)
5. Strong communication skills, verbal and written
6. Working knowledge of Excel, Word, Power Point
7. Accepting constructive criticism and dealing calmly and effectively with high-stress situations. This includes continuing to persevere and remaining calm in challenging or frustrating circumstances
8. External Focus: Understanding customer needs, marketplace dynamics, industry trends, and the competitive landscape in the industry/function and considering the external impact of business activities and decisions on the external environment
9. Inclusiveness: Energizing others by building a connection with the team through personal involvement and trust and providing feedback and coaching to help develop others
10. Clear thinker: Simplifying strategy into specific actions with clear accountability, making decisions with speed and accuracy based on best available information, and communicating priorities clearly and concisely
11. Experience with some or all of the following:
? Design controls, design verification and validation activities
? Production and process controls
? CAPA, complaints and risk management
? Understanding of product quality improvement using tools such as Six Sigma
? Experience performing internal audits
? Experiences in Process Intensive manufacturing

Medline麦朗公司始建于1966年，现在发展为国际性医疗用品制造商和经销商，产品种类多达30多万种。年销售额连续50多年持续增长：2020年总销售额超过175亿美元，2021年总销售额递增15%，超过200亿美元，名列2021年全球医疗器械企业100强第6位。麦朗有超过28,000名员工，业务分布于全球125个国家。

Our Website: https://medlineasia.com.cn/