招聘人数：1-2人
到岗时间：不限
年龄要求：不限
婚况要求：婚姻状况
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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