Specialist, Quality Compliance
想象一下你的想法和专业知识如何改变患者的生活。我们的质量团队帮助塑造了创新技术的发展，以确保我们创新过程中的每一个阶段都保持最高标准的完整性和安全性。你将带来你对解决问题的热情，并与各种团队合作，影响产品整个生命周期的决策。你的工作将涉及到优化产品开发，以先驱技术影响世界各地的患者。患有中枢和三心脏门疾病的患者往往具有有限治疗选择的复杂条件。我们的跨管中心和三脑治疗 (TMTT) 业务部门正大胆地追求一种创新技术组合来满足患者未得到满足的临床需求。它是我们推动力，帮助病人过长时间更健康的生活。加入我们并成为我们的鼓舞人心之旅的一部分。在这个角色上，你将应用专业知识和判断力来支持质量遵守活动和商业成果。你如何产生影响：·评估提供的投诉信息；评估每个事件以确定是否符合投诉条件；根据适当情况升级 · 在调查和解决投诉过程中管理客户关系和期望 · 进行研究，寻求产品安全，工程和其他部门/业务单位的信息和输入以及酌情挑战投诉调查 ·识别问题并领导改善流程，程序和/或实践的项目；建议解决方案，包括制定新的方法来解决遇到的问题 ·评估医疗设备报告 (MDR) 的投诉；为 FDA 编制和提交 MDR 报告 · 总结调查，产品分析，成像检查，使用说明 (IFU) 和任何其他相关标签和/或培训材料的结果，并制定结论 · 准备和提交最终客户信件 · 领导层所分配的其他职责 （可能协助审核投诉文件）你需要什么：· 3年经验处理投诉或基于爱德华兹标准等同的工作经验 我们寻找什么 （最喜欢）: · 在 MS Office Suite 中获得证明的专业知识以及运行一般办公机械的能力 ·医疗器械 （心血管，内血管或其他关键护理/外科产品）,卫生保健或相关环境或等级
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Imagine how your ideas and expertise can change a patient’s life. Our Quality teams help shape the development of groundbreaking technologies to ensure each stage of our innovation process is held to the highest standards of integrity and safety. You’ll bring your passion for problem solving and partner with various teams to influence decision-making for a product’s entire lifecycle. Your work will involve you optimizing product development to impact patients around the world with pioneering technology.
Patients with mitral and tricuspid heart valve disease often have complex conditions with limited treatment options. Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit is boldly pursuing an innovative portfolio of technologies to address a patient’s unmet clinical needs. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey. In this role, you will apply professional expertise and judgment to support quality compliance activities and business outcomes.
How you will make an impact:
- Assess complaint information provided; evaluate each event for determination if it qualifies as a complaint; escalate as appropriate
- Manage customer relationships and expectations during the course of complaint investigation and resolution process
- Research, seek information and input, and challenge as appropriate, from Product Safety, Engineering and other departments/business units for complaint investigations
- Identify problems and lead projects to improve processes, procedures, and/or practices; recommend solutions, including devising new approaches to problems encountered
- Evaluate complaints for Medical Device Reporting (MDR); prepare and submit MDR reports to FDA
- Summarize findings, including a review of the investigation, product analysis, imaging review, instructions for use (IFU), and any other relevant labeling and/or training materials, and formulate conclusions
- Prepare and submit final customer correspondence
- Other duties assigned by Leadership (May assist in auditing complaint files)
What you'll need (Required):
- 3 years’ experience complaint handling or equivalent work experience based on Edwards criteria
What else we look for (Preferred):
- Proven expertise in MS Office Suite and ability to operate general office machinery
- Medical device (cardiovascular, endovascular, or other critical care/surgical products), healthcare, or a related environment or equivalent work experience based on Edwards criteria preferred.
- Excellent written and verbal communication skills and interpersonal relationship skills
- Experience working in a medical device (cardiovascular, endovascular, or other critical care/surgical products), healthcare, or a related environment required
- Demonstrated problem-solving , critical thinking, and investigative skills Ability to build stable working internal/external relationships
- Full knowledge and understanding of Edwards policies, procedures, and guidelines relevant to quality compliance
- Good knowledge of medical terms and human anatomy
- Full knowledge of Medical Device Reporting regulations, and regulatory reporting regulations
- Good knowledge of Good Documentation Practices (GDP) as it relates to complaint filing
- Ability to manage confidential information with discretion
• Attention to detail
- Ability to interact professionally with all organizational levels
- Ability to manage competing priorities in a fast paced environment
- Must be able to work in a team environment, including inter-departmental teams and representing the department on specific projects
- Ability to build productive internal/external working relationships
- Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
Originally posted on Himalayas