深圳 [切换城市] 深圳招聘深圳质量管理/安全防护招聘深圳质量管理/测试工程师(QA/QC工程师)招聘

Senior Quality Engineer & ISO13485 Specialist

宝安区西乡后瑞年利亚电子制品厂

  • 公司规模:1000-5000人
  • 公司性质:外资(欧美)
  • 公司行业:电子技术/半导体/集成电路

职位信息

  • 发布日期:2012-12-24
  • 工作地点:深圳-宝安区
  • 招聘人数:1
  • 工作经验:八年以上
  • 学历要求:本科
  • 职位类别:医疗器械生产/质量管理  质量管理/测试工程师(QA/QC工程师)

职位描述

Job Overview:
The Senior Quality Engineer and ISO13485 Specialistrole is responsible as the key liaison between manufacturing and the customer, ensuring that overall customer quality, expectations and product meets all specifications. Responsible for minimizing costs of poor quality and maximize customer satisfaction through coaching and supporting improvements in quality and writing effective quality instructions and procedures. You will be responsible for our ISO13485 and FDA QSR compliant line of Personal Emergency Reporting Systems products. You will lead the quality improvement team that will include engineers from various disciplines to improve both product quality and compliance. You will also be part of the FMEA team; put into place solid Quality Control Plans to reduce risk as well as train coach and instruct operators. You will also establish and perform routine system and production audits to ensure systems integrity and compliance. You MUST have a minimum of 7 years of solid working experience with ISO13485 systems. FDA QSR experience is not required but is a big plus.

Responsibilities:
1. Customer First!
a. You will be the primary customer interface for all customer quality specifications and requirements.
b. Assure that new and existing customers quality requirements are understood, followed and flowed-down to all relevant functions.
c. Facilitate all quality-related activities associated with customer product introductions
d. When necessary, to support the quote and contract review process, ensuring customer quality requirements are met.
2. Continuous Improvement
a. Initiate, implement and coordinate meaningful and measurable proactive quality initiatives, continuous and preventative improvement programs, etc.
b. Troubleshoot quality complaints or problems and recommends and/or implements resolutions.
3. Corrective Action& ECO
a. Facilitate EFFECTIVE and measurable resolution of reactive quality initiatives;containment/root cause/corrective actions, customer issues, etc.A hands-on approach is essential.
b. Support product and process changes and evolution, ensuring product quality integrity is maintained. Approval of all product changes (ECOs, deviations, validations, etc.) to ensure customer requirements and expectations are met, and verification that changes are correctly implemented
4. Monitor &Reporting
a. Create, implement, maintain and monitor meaningful processes auditing, metrics, etc. to ensure product health.
b. Facilitate and participate in quality metrics reporting and communicating the findings to the appropriate parties.
5. Documenting
a. Define, document and manage all customer quality plans.
b. Write meaningful quality instructions for both the manufacturing and quality team in order to ensure customer satisfaction and product quality.
6. Coaching & Training
a. Train and work with quality inspectors to ensure that the customer's requirements are fully understood. A hands-on approach is essential.
7. Auditing
a. Conduct and facilitate internal ISO13485 and FDA QSR auditing of departments for continuous improvement
b. Perform project and process audits to ensure compliance

Qualifications:
· MUST have a minimum of 7 years of experience working in an ISO13485 environment
· MUST know and understand ISO13485, perform FMEAs and put into place solid quality control plans that minimize risk
· MUST speak, read and write fluent English and Putonghua
· MUST have confidence to be able to respond to and speak directly with US based customers
· All candidates MUST have legal authorization to permanently live and work in China without visa or employer sponsorship
· MUST understand IPC-A-610 Standardsand 8D practices

Education/Experience:
· A minimum of a Bachelor's degree, EE or ME preferred, with minimum of 5 years of Quality experience with an EMS company.

Behavioral Skills:
· An excellent communicator and team player
· Highly self-motivated
· Passionate about quality and continuously seeks to improve processes or structure.
· Logical and thorough in determining root cause and in articulating
· Hands on approach and work with other in order to ensure product quality

Plusses
· Working knowledge of Lean, DFT and Six Sigma is a big plus
· Working knowledge of ISO90001 is a big plus
· Working knowledge of PDCA & FMEA is also a plus

公司介绍

    年利亚电子制品厂是美国年利亚电子集团在中国的生产基地,主要为集团装配电子产品,主要产品有:电子防盗系统、多媒体音视频信号放大转接系统、车库开关装置、电源保护装置、音乐服务器、音箱及配件、家用吸尘器等。
    美国年利亚电子集团有超过五十年历史,上世纪80年代,集团设厂于香港,至90年代转移到深圳,工厂位处深圳宝安区,邻近深圳机场,交通便利。随着母公司美国年利亚电子集团的扩张,公司亦不断发展壮大,目前在职员工1800多人。
     公司自建厂伊始即致力于人才的建设,现诚邀各领域精英的加入。


 Company name:Hourui Linear Electronics Manufactory
 URL: www.linearcorp.com
 
    Are you ready to experience the difference Linear LLC is a pioneer in wide range of radio frequency and consumer electronic products including wireless residential security systems, garage door operators, medical/emergency reporting systems, whole house audio/video distribution systems, music/communications systems to name but a few. At Linear you will work with knowledgeable employees in a global spirit of cooperative teamwork, integrity and drive. Together we will transform our customer’s cutting edge ideas into market leading products by employing a wide variety of services including product design, state-of-the-art prototyping, test solutions and higher-level assembly. At Linear we take pride in our employees and our services. Join our team today and experience the difference that Linear has to offer.


联系方式

  • 公司网站:http://www.linearcorp.com
  • 公司地址:深圳市宝安西乡后瑞第二工业区6栋
  • 邮政编码:518128
  • 联系人:人事部吴小姐
  • 传真:(0755)29798051
  • 电话:(0755)27511132