招聘人数：1-2人
到岗时间：不限
年龄要求：不限
婚况要求：婚姻状况
Position: Quality Manger - Value Segment Solutions
Location: Shanghai
Your challenge This is a position for an experienced medical device Quality Assurance Manager who, under general supervision, will support the business staff and act as a primary liaison to the business regarding product/process quality and compliance issues.
Duties and responsibilities include: ?
Preview, review, and approval of engineering change orders
? Review and approval of product/process validation and verification protocols/reports
? Review and approval of nonconforming material documentation
? Provide process validation leadership
? Represent quality on initiative teams (process improvement/implementation) strongly championing business needs
? Supports partnership assessment and supplier selection processes as necessary
? Interface in manufacturing and design change process including process audits, process verification and validation audits
? Quality Engineering process consulting
? Responsible to support and be knowledgeable of business specific standards
? Influences supply chain processes to improve quality and reliability of products
? Supports quality reliability team activities
? Independent reviewer for design reviews
? Conduct Design History File audits
? Participate and review design control activity.
? Review product and process control activity.
? Maintains current knowledge of applicable national and international regulations, acts as a consultant to other departments.
? Perform other duties as assigned by BIU Q&R Director Requirements:
? BS in engineering discipline or equivalent education, experience, training.
? At least 7 years quality experience in medical device industry
? Strong understanding of Quality System regulations (FDA, ISO13485).
? Good understanding of statistical methods, quality tools and methodologies (SPC, FMEA, DOE, etc.)
? Well-developed organizational and analytical skills
? Proven ability to lead diverse discipline teams, understand and identify relationships and interdependencies across multiple projects and initiate team building
? Communicate globally, across teams and programs, from senior executives to administrative support personnel.
? Both detail oriented and able to see big picture
年薪40-50万
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