常州招聘

ESSENTIAL FUNCTIONS:

· Maintain an in-depth working knowledge of ISO and FDA requirements.

· Perform internal audits to ISO 13485 and FDA QSR requirements.

· Understand, practice and enforce corporate policies and procedures.

· Provides administrative support to the quality department staff, which involves prioritization of tasks and may include handling confidential information.

· Track and maintain divisional metrics for quality

· Attend IRB meetings to ensure on-time delivery of responses to customer requested corrective actions. Alert Director of Quality Manager of roadblocks.

· Handle calls from customers and the 3^rd part concerning audits.

· Maintain non-conformance database and the CAR database. Track and trend data to present to IRB and upper management.

· Organize filing systems for customer and suppliers.

· Track and trend all customer Delivery and Quality scores and distribute to appropriate departments.

· Maintain device history records.

· Process expense reports.

· Arranges and set up of meetings including catering.

· Assist with reports, spreadsheets, graphs, and presentations.

· Control and maintain Quality Manual, corporate procedures, SCP’s, work instructions, and forms.

· Assures compliance with record retention policies.

· Maintain and track customer confidentiality agreements.

OCCASIONAL DUTIES:

· Miscellaneous filing as required.

· Ordering departmental supplies as required.

· Covering Receptionist/Switchboard Operator as required.

· Other duties as required.

· Back up for Calibration Technician

· Training of quality procedures and practices across functional disciplines.

· May travel to other divisions as required.

· Once employee demonstrates competency in position, he/she may be required to train others in similar roles.

EDUCATION/EXPERIENCE:

· College education or over.

· 3years or over 3 years experience on ISO13485, FDA QSR or TS16949 is preferred.

SKILLS:

· Interpersonal communication and teamwork skills required.

· Strong organizational and problem-solving skills.

· Ability to handle multiple tasks in a fast -paced environment.

· Ability to perform diversified tasks

· Flexibility to work overtime

· Computer literacy and proficiency with Word and Excel.

· Exceptional attention to detail required.

· Excellent oral, written, and telephone communication skills.

· Ability to administer projects that have company-wide impact.

· Ability to apply company policies to problems or situations that arise.

派瑞格集团位于世界外科医疗的“首都”-美国沃索，是首选的、可提供世界一流水平系统方案的“交钥匙”供应商。派瑞格集团自1991年成立以来，在美国、欧洲和亚洲创建了卓越的战略中心，工厂分布在美洲和亚洲，长期为世界顶尖的医疗器械生产商配套，同时也为中国国内顶尖的医疗器械生产商服务。设在美国的“全球设计中心”将服务从专业制造延伸到了客户的产品研发和样品试制，通过独特的质量管理体系，派瑞格承诺给世界范围的医疗器械行业的OEM商提供创新的、快速响应的系统方案。
派瑞格医疗器械（常州）有限公司创建于2007年5月，投资总额1850万美元，是美国派瑞格医疗国际公司在亚洲投资的全资美资公司，是派瑞格集团亚太区重要的出口生产基地。公司给全球一流的医疗器械公司专业生产符合不同国家法律法规要求的一类骨科医疗器械，器械盒和托盘，三类6846植入材料和人工器官的制造等，并可设计并销售自产产品。
我们的远景：成为全球外科手术市场上产品和成套器械管理方案的首选供应商。
我们的使命：通过设计和提供高精密的医疗器械产品，高效及时交付系统，试验和植入器件来服务于全球外科手术器械市场。
我们的质量方针：第一次就把事情做对。
更多企业信息，请关注我们的企业网站：http://www.paragonmedical.com