长沙招聘

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.

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 ******.

关于BD

BD是一家全球化的医疗技术公司，通过改善医学发现方法、医疗诊断效果和护理质量以引领世界健康。BD关注并支持每位一线医务工作者，致力于通过研发创新技术、服务和解决方案，帮助患者改善临床治疗，并帮助医护人员改进临床流程。BD及其65,000名全球员工秉承高度的热情和信念，致力于帮助提升患者的治疗效果，为临床医护人员提供安全、高效的护理给药流程，协助实验室科学家们更有效地诊断疾病，并提升科研人员研发新一代诊断及治疗疾病的能力。BD在几乎所有国家均设有分支机构，与全球范围内的组织机构积极合作，携手应对最具挑战的全球健康问题。通过与客户的紧密协作，BD以改善治疗结果，降低医疗成本，提升诊断效率为己任，帮助加强患者和医护人员的安全并扩大医疗可及性。2017年，BD欢迎巴德及其产品加入BD大家庭。更多信息，敬请访问**********/china。