莆田招聘

职位描述：

Title: Quality Engineer

Report to: Quality Manager

Location: Suzhou (江苏省苏州市苏州工业园区白榆路5号)

Travel Frequency: 25%

Position Summary

Performs quality assurance activities to
ensure compliance with applicable medical device regulatory requirements.
Contributes to the completion of specific programs and projects usually under
the direction of a project leader. Good understanding and frequent
application of quality assurance principles, concepts, industry practices, and
standards. Works under general direction while independently determining
and developing approaches to solutions. Frequent inter-organization and
limited outside customer contacts.

Key Responsibilities

·
Quality
System

o Able to comprehend Quality System requirements; plan, prepare and
execute systems to ensure compliance with QSR, ISO, and EN requirements.

o Review and improve existing quality
procedure workflows and identify areas of improvement for efficiency.

o Conduct quality audits at own and
vendor locations to assess compliance to applicable standards and regulations;
prepare and execute action plans to improve overall compliance.

o Independently author concise quality
investigation reports with appropriate corrective action and preventive actions
(CAPA)

o Review new and modified product design
specifications including product performance specifications, test methods,
acceptance criteria, and release to manufacturing.

o Understanding and coaching others on
Quality Systems and procedures.

·
Product
Development

o Contribute as a team member on
development projects carrying out assigned quality assurance responsibilities
in a timely, diligent, safe, and professional manner.

o Contribute to development and
maintenance of Design History Files in a manner consistent with regulatory
requirements.

o Provide quality-related inputs to
projects on product reliability, in meeting quality deliverables.

o Guide the development of quality plans,
execute inspection & testing activities and work further with Manufacturing
on the transfer of quality requirements.

o Provide statistical inputs on product
testing and control of quality characteristics.

o Support R&D in device
product/process development and production activities.

o Perform trend analysis, risk
management (such as FMEA, Hazard Analysis, Fault Tree) and six sigma tools

Education

 
• Minimum

o Bachelor’s degree in mechanical
engineering or related discipline.

o Professional certifications, such as Certified
Quality Engineer or Certified Quality Auditor.

Experience

 
• Minimum

o 2 years relevant experience in quality
record documentation and quality system requirements, GMP compliance, quality
auditing, and CAPA systems.

o Practical and demonstrated experience
of Quality or Reliability engineering/QA/QS, risk analysis, product development
and verification/validation testing.

 
• Desired

o Demonstrated hands-on experience with
Design Control procedures.

o Experience in the design and
development of products in accordance with ISO 13485 guidelines.

o Experience in high volume
manufacturing and assembly processes, particularly those of plastic injection
molded parts and assemblies.

Required Knowledge and Skills

 
• Minimum

o Good working knowledge of medical
device regulations and practices (ISO 13485, FDA QSR, etc.).

o Fair understanding of quality
assurance principles, concepts, industry practices, and standards.
General knowledge of related technical disciplines.

o Familiarity with statistical methods
and analysis and/or Minitab software.

o Good knowledge and understanding of
process development, total quality tools, and continual improvement approaches.

o Ability to recognize deviations from
accepted practice and apply knowledge of Design Control on a daily basis.

o Team player with excellent
interpersonal and communication skills.

o Proven ability to work independently
with a minimum of supervisor input.

 
• Desired

o Excellent technical writing skills.

o Familiarity with Six Sigma
methodology.

o Disciplined and well-organized in
documentation (plans, requirements, drawings, design reviews, and test
methods).

o Strong critical thinking, analytical,
and problem solving skills.

o Demonstrated ability to quickly learn
new subject matter.

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BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. The company supports the heroes on the frontlines of health care by developing innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for healthcare providers. BD and its 65,000 employees have a passion and commitment to help improve patient outcomes, improve the safety and efficiency of clinicians’ care delivery process, enable laboratory scientists to better diagnose disease and advance researchers’ capabilities to develop the next generation of diagnostics and therapeutics. BD has a presence in virtually every country and partners with organizations around the world to address some of the most challenging global health issues. By working in close collaboration with customers, BD can help enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care. In 2017, BD welcomed C. R. Bard and its products into the BD family. For more information on BD, please visit ******.

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