BD (Becton, Dickinson and Company) Jobs

Job Information

BD (Becton, Dickinson and Company) 质量工程师_R&D_上海 in Shanghai, China

Job Description Summary

Job Description

Job Title 职位 : Quality Engineer

Department 部门 : Unit QA

Job Location : Shanghai

Job Grade 职级 : 3

Report to 汇报人职位 : Quality Engineering Manager

Subordinates下属 : 0

POSITION SUMMARY(职位概述)

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(主要职责)

• 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.

SKILLS AND ABILITIES(技能)

• Minimum

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

• Education and experience Minimum

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

o Above 3 year in quality assurance role

o Professional certifications, such as Certified Quality Auditor.

DESIRABLE(优先条件)

  1. Medical device/Pharmacutical company working experience

  2. Design assurance experience

Working conditions & environment(工作状况和条件):

(如是否需要经常出差? Home based?)

  1. Business travel required. 30%

Travel Frequency

0

<25% √

25%-50%

50%-75%

75%

while independently determining and developing approaches to solutions. Frequent inter-organization and limited outside customer contacts.

KEY RESPONSIBILITIES(主要职责)

• 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.

Job Description

POSITION SUMMARY(职位概述)

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.

Primary Work Location

CHN Shanghai - HQ

Additional Locations

Work Shift

BD is a leading global medical technology company that creates medical technology, devices and laboratory equipment for a variety of needs across the healthcare continuum. At BD, we are looking for candidates who possess passion, innovative solutions and a commitment to our one mission of improving access to groundbreaking medical and biotechnology services for people near and far, delivering state-of-the-art technology and cutting-edge research in the battle to fight and cure infectious diseases. With a global reach that extends across 50 countries worldwide, our network of professionals collaborates on effective measures to deliver enhanced patient quality such as lower health care delivery costs, improved health care and safety, and expanded health care for all. Join our company and see how you can become a part of one global mission to make a difference in human health.

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

All applicants should complete the on-line application process. BD is committed to working with and providing reasonable accommodations to individuals with disabilities. If you require assistance or an accommodation because of a disability to participate in the application process, please call 855-BD-HELPS (855-234-3577) or email asc.americas@bd.com

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