质量工程师
美国医德宝医疗康复器械股份有限公司ShenzhenUpdate time: August 20,2019
Job Description

JOB TITLE: Quality Engineer- component

DEPARTMENT: QA


REPORTS TO: Quality& Compliance Senior Manager, China


FLSA STATUS: Exempt

Revision Date: Apr 9, 2019


GENERAL STATEMENT OF DUTIES:

The quality engineer is responsible to oversee and manage the total quality process (product development, supplier quality management and after-sales services support) and to ensure the quality of the component can satisfy specification, customer and compliance requirement.

This position requires extensive experience of working collaboratively alongside with suppliers, customers and internal PD/PM/SM team to develop and implement Quality improvement.

Goals/Mission:

l Support line manager to develop component quality management process and implement defined process within Drive Asia QA organization and across Drive Asia suppliers.

l Support line manager to develop supplier quality control process, implement the defined process across Drive Asia supplier base.

l Support sourcing team in component development and quality control.

This role requires considerable travel and on-site participation at supplier.


ESSENTIAL DUTIES AND RESPONSIBILITIES:

l Execution, maintenance and development of products' quality program as well as related systems in co-operation with suppliers.

l Set up inspection spec/criteria and method for components.

l Set up testing protocols for components and follow up components testing and ORT.

l Implement supplier quality system audit, process audit and product audit at supplier site and follow up supplier’s corrective actions.

l Handling customer complaint of component quality issues.

l Lead and coach Quality Technician and Quality Inspectors to ensure effective and efficient product inspection process implementation at supplier side.

l Participate in new product NPI as quality role, and participate in new product pilot run and conduct first article/random inspections amount the manufacturers.

l Participate supplier qualification activities for new suppliers.

l Monitoring supplier performance trends, making regular statistical analysis report, e.g. LRR/ PPM tread, follow up supplier quality improvement plan.

l Lead quality problem investigation and solving, be responsible to follow up Supplier CAPA and ensure its on time completion.

l Train and develop supplier Quality personnel in best practice, tools and processes to deliver World Class Quality Management Systems.

l Improve supplier's manufacturing process and out-going quality;

l Work closely with inter and cross function teams for project management and manufacturing status monitoring;

l Managing engineering changes across suppliers to ensure the best implementation of changes.

l Other assignment and project designated by line manager.


SUPERVISORY RESPONSIBILITIES:

N/A


PHYSICAL DEMANDS:

Must possess sight/hearing senses, or use prosthetics that will enable these senses to function adequately so that the requirements of this position can be fully met. Physical activity includes

walking, standing, bending, squatting, reaching above shoulders and lifting up to 40lbs. Must be able to drive an automobile for short and long distances.


This position requires sitting for a long period of time.


WORK ENVIRONMENT:

Performs office activities in a lighted and ventilated area. May be subject to changes in temperature and exposure to dust. Will be exposed to uncontrolled environmental conditions during driving. Will work in a normally acceptable office environment, with no abnormal hazards or risks. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.


QUALIFICATIONS, KNOWLEDGE, AND SKILLS:

  • Detailed understanding of World Class Quality Management principles and their application within complex industrial environment.
  • Familiar with ISO9001 or ISO 13485 quality system.
  • Familiar with in molding, metal machining process.
  • Experience in the use of advanced Quality Management tools and processes, such as SPC, FMEA, PPAP, APQP, MSA and AQL sampling etc.
  • High degree of initiative, accountability and ability to work with minimal instruction.
  • Strong leadership / Teamwork / Interpersonal skills and possess desire to succeed
  • Change management and control skills.
  • Well -developed analytical and problem solving ability and use of 8D.
  • Effective verbal and written communication in English and Mandarin.
  • Expertise in standard desktop applications, especially those used in the development of presentations, to include Microsoft Word, Excel and PowerPoint.
  • Must be able to prioritize multiple projects and responsibilities.
  • Thorough understanding of financial impact of decisions.


EDUCATION AND EXPERIENCE:

  • Bachelor’s Degree; or 7-10 years related experience and/or training/ or equivalent combination of education and experience preferred.
  • Solid work experience on mechanical design / quality / engineering discipline
  • Quality Management in a Manufacturing/Engineered Product environment.
  • Interfacing and collaborating with suppliers and customers
  • Proven track record of quality improvements in industrial environments.


CERTIFICATES, LICENSES, REGISTRATIONS


N/A




职能类别:质量管理/测试工程师(QA/QC工程师)


上班地址:深圳市福田区福田街道福山社区福华三路3号京地大厦803

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