招聘人数：若干
到岗时间：不限
年龄要求：不限
婚况要求：婚姻状况
语言要求：
英语
Basic Function:
The AQE-New Product Development (NPD) will be responsible for quality system support for R&D projects; provide inputs to R&D designs from a quality perspective; work closely with R&D to develop test strategies for product designs and analyze the risk associated with these designs; provide statistical support and analysis; improve quality processes as they apply to new product design.
Responsibilities:
Help guide R&D through our internal quality system to ensure products are developed in compliance to those procedures as well as the requirements of the FDA, ISO, and other regulatory bodies.
Review and evaluate project documentation for compliance as well as sound technical competence to ensure we are delivering robust products/processes.
Support process and product validation programs for new product development.
Involved in developing, modifying, and executing regulatory related company guidelines and procedures.
Provide input throughout the new product development process from a quality perspective.
Perform risk analysis and develop mitigation strategies
Collaborate with Design engineers to develop robust verification test strategies to ensure safe, reliable products are implemented.
Educate R&D on the use of risk management tools, statistical methods, design and process control activities, and sound verification and validation test planning to help drive quality upfront in new product development.
Perform supplier development activities surrounding PPAP
Develop and create procedures for incoming, in-process, and final inspections for new product development
May conduct internal Quality system audits and be involved with CAPA projects.
May be involved in Quality related continuous improvement projects for the organization
May have involvement in training others on QA topics.
Qualifications:
5 + years experience in an engineering/manufacturing environment or in quality engineering role within a medical device or pharmaceutical environment
Experience with medical device development and manufacturing
Experience in a Quality role familiar with FDA and ISO requirements.
Working knowledge of Risk Analysis, GD&T, SPC, Root Cause Analysis, Statistics and practical applications
Excellent analytical and problem solving skills
Excellent interpersonal skills
Excellent organizational skills
Process validation experience; preferred knowledge of GHTF approach to validation
Working knowledge of FDA, ISO, and other regulations and standards
ASQ Certifications (CQE, CRE, CQM, CSSBB)
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