宜兴招聘

Essential Responsibilities
Direct the Site Quality Management System, fully integrated into the company Corporate Quality Management System, including cross-functional and site-specific processes. The role is responsible for facility compliance covering voluntary, regulatory and company quality requirements and will champion quality initiatives at all levels of the organization.
Maintain and improve all aspects of Site Quality Planning.
Ensure consistent application of plans and programs to drive compliance for all applicable governmental regulations (ISO13485, FDA, MDD, MHLW, CFDA, KFDA, Health Canada, etc.)
Oversee all Quality-related communications and training requirements for all site employees.
Establish positive relationships with outside agencies.
Partner effectively with Engineering, Global Supply Chain, and other departments to ensure quality standards are being met at the site.
Ensure site audit readiness and hosting Quality System audits and inspections.
Oversee the Corrective Action / Preventive Action activities and Complaint Handling Programs, and in some cases, Quality Engineering.
Drive site quality objectives, metrics, reporting and operating mechanisms.
Conduct analysis of quality indicators to identify trends, initiate investigations, and implement appropriate corrective actions.
Evaluate staffing needs and costs related to the Plant Quality teams; identify, hire, and promote individuals with the correct skills and competencies to achieve superior results
Report on Quality System effectiveness and requirements to management team as required including preparing and executing facility Quality Management Reviews.
Participate in selected global initiatives to share best practices and leverage quality synergies.
Support local R&D programs and quality issue resolution.
Act as Management Representative for Quality at the Site.
Additional responsibilities as requested or required

Qualifications/Requirements
Bachelor's degree in Engineering, Medical Device Technology or Scientific Field, and a minimum of 5 years of professional experience and understanding of product development, manufacturing, quality control and servicing in a medical equipment or pharmaceutical industry.
Minimum 3 years supervisory/ management experience, including hiring, training, coaching and performance management activities.
Hands-on experience with FDA QSR, ISO, MDD and/or other international quality systems requirements with strong practical design control experience.
Ability to read, analyze, and interpret business plans, technical procedures and governmental regulations.
Effective report, business correspondence and procedure writing skills.
Good problem identification, multivariable analysis and creative resolution aptitude.
Proven process development and project management skills.
Strong computer skills.
Ability to communicate proficiently using both English and Chinese

Desired Qualifications
Five or more years of management/leadership and development experience in quality assurance/compliance/regulatory within a Medical Device industry
Extensive knowledge of medical device development life cycles, quality systems, FDA 21 CFR's 803/806/820 and ISO 13485 and other regulations related to medical devices
Demonstrated experience working in a cross-functional environment and proven ability to influence and build consensus among multiple functions.
Demonstrated ability to effectively lead professional staff, proven ability to work in a collaborative team environment across multiple functions
Demonstrate proven critical thinking, people and team development skills, strategic aptitude, and independent leadership
Experience in a global, matrix organization structure.
ASQ Certified Manager of Quality/Operational Excellence (CMQ/OE), ASQ Certified Quality Engineer (CQE), ASQ Certified Quality Auditor (CQA), or equivalent preferred.
Prior experience in audits preferred
Six Sigma training and/or certification preferred
Team player with a global mindset.
Strong Change Acceleration skills.
Front line operational responsibility in Engineering, Manufacturing or Supplier Management
Excellent interpersonal skills (including listening, writing, negotiation, facilitation, attention to details

当你十年寒窗苦读毕业，怎样接轨社会开启自己成功的职业生涯？当你认真工作，努力向上可曾想过应该再弥补些什么知识？ 当你的同事获得提升而不是你的时候，你可知道自己哪里做的不到位？当你郁闷无比，又无法直抒胸臆时应该怎样主动解决当前状况？
    
    人生的机遇充满了选择、惶惑与挑战， 什么才是最适合自己的路？-- 临渊羡鱼，不如退而结网
    
    苏州西艾信息咨询有限公司，是一家从事职业规划，中高级猎头、背景调查、整体招聘解决方案以及企业管理咨询的专业机构，我们致力服务各类企业团队建设，并积极为个人提供职业发展规划建议以及能力提高的方式方向指导。客户与候选人的双赢是我们追求的永恒目标。我们服务过的行业包括快速消费品，化工，半导体，IT, 医药, 工业，装配生产以及研发领域。西艾咨询将坚持遵循高度的职业伦理，秉承“合作、高效、客观”的作风，为企业和职场人提供更为优质的服务。
     
     西艾咨询的愿景：
 成为口碑最好的职业规划平台
 做优质企业与人才的最佳桥梁
     
     西艾咨询的主要服务内容包括：
 职业规划
 中高级猎头服务
 背景调查
 整体招聘解决方案
 性格与高考志愿选择服务
Email: hr@3L-consulting.cn