Engineer QA
工作总结 职务简介 工作总結：质量工程师是 Medline 的一些部门的重要支持角色。他/她将从质量角度提供建议或评论，以便其他部门 （即 QA,PM 或采购）能够为完成所有分配项目做出贡献。工作责任：·确保供应商对各种医疗设备相关的所有公司和国际标准，流程和程序清楚。·按照公司和国际标准进行符合性和成品验证以保证可接受的质量。· 与其他功能团队 （QA 和 PM）合作确定产品的适当测试参数，以确保产品中有限的故障。·执行过程审计并确定对流程控制，生产控制和质量控制的持续改进机会。·从质量角度负责与供应商的项目，具体来说，关于产品设计变化，质量性能提高以及监控关键产品的质量表现。·与美国的供应商和公司公司办公室一起帮助解决各种客户投诉。特别是，协助根源调查和分析。根据根源调查实施 CAPA,以减少投诉数量。确保质量问题解决方案得到适当的实施和维护。· 与供应商和中国公司 QC 团队合作，减少产品拒绝。·与供应商合作，确定带来节省成本的产品和工艺改进机会。· 与提供商合作验证和优化生产参数并确保供应商在实施后正确记录和验证这些参数。资格：·机械工程或材料学士学位，或者工业工程师或医疗器件相关的工程领域所需。· 3年以上工程经验，项目管理优先 · 过程控制和质量控制要求 · 理解质量系统要求 （ISO 13485或 ISO 9001）·阅读和解释产品规格和图纸的能力 · 有强有力的书面和口头沟通，解决问题和组织技能的细节导向性 · 高度的专业态度，更高的紧迫感以精确有效地完成任务。· 能够有效识别并建议成品，工艺和文档改进。
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Job Summary
Job Description
Job Summary:
Quality engineer is an essential support role for certain division in Medline. He/She will be providing suggestion or comment from quality perspective for other department (i.e QA, PM, or Sourcing) to contribute in completion of all assigned project.
Job Responsibilities:
- Ensure suppliers are clear on all Company and International standards, processes and procedures as they relate to various medical devices.
- Perform in line and finished product verification in accordance with Company and International Standard to ensure acceptable quality.
- Work with other functional team (QA and PM) to determine appropriate testing parameters for the products to ensure limited failures in product.
- Perform process audits and identify opportunities for continuous improvement on process control, production control and quality control.
- Be responsible for projects with vendors from a quality perspective, more specifically, on product design change, quality performance improvement, and monitoring quality performance on critical products.
- Work with Suppliers and Company corporate office in US to help resolve various customer complaints. Specifically, help with root cause investigations and analysis. Implement CAPAs based on root cause investigations to reduce complaint numbers. Ensure that solutions to quality issues are properly implemented and upheld.
- Work with suppliers and Company QC team in China to reduce product rejections.
- Work with suppliers to identify opportunities for product and process improvements that lead to cost savings.
- Work with supplier to validate and optimize the production parameters and ensure suppliers properly document and verify these parameters once implemented.
Qualifications:
- B.S. Degree in Mechanical Engineering, or Material, or Industrial engineer or Medical device related engineering field required.
- 3+ years of engineer experience, project management is preferred
- On process control and quality control is required
- Understanding of quality system requirements (ISO 13485 or ISO 9001)
- Ability to read and interpret product specifications and drawings
- Detail oriented with strong written and verbal communication, problem solving, and organizational skills
- Professional attitude with a heightened sense of urgency to complete tasks accurately and efficiently.
- Ability to effectively recognize and suggest improvements for finished products, processes and documentation practices to suppliers, managers, and coworkers.
- Proficiency of PC skills: AutoCAD or SolidWorks, MS Word, MS Excel, Adobe and E-mail
- Available to travel frequently.
- Excellent English speaking, reading and writing skills.
- Capable of handling special projects as directed by Managers.
Our benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average. For a more comprehensive list of our benefits please click here. For roles where employees work less than 30 hours per week, benefits include 401(k) contributions as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp.
We’re dedicated to creating a Medline where everyone feels they belong and can grow their career. We strive to do this by seeking diversity in all forms, acting inclusively, and ensuring that people have tools and resources to perform at their best. Explore our Belonging pagehere.
Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified individuals without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, age, disability, neurodivergence, protected veteran status, marital or family status, caregiver responsibilities, genetic information, or any other characteristic protected by applicable federal, state, or local laws.
Originally posted on Himalayas