Cynet Systems
Job Description:
Pay Range: $51.72hr - $53.79hr
Responsibilities:
Conduct product complaint investigations and write failure investigation reports. Ensure accuracy for complaint file documentation and regulatory reporting decision activities. Ensure timely follow-up with customers and company representatives for reported issues. Ensure complaint files are accurate and complete, and in line with good documentation practices. Assist regulatory reporting activities to ensure medical device reports are submitted within required timeframes and company policy. Demonstrate sound independent decision-making in regard to medical device reporting and other functions relating to the investigation of product complaints. Provide or facilitate clinical expertise and troubleshooting for customers as appropriate. Collaborate with supervisor, manager, and/or department RNs to assess the severity of complaints and understand typical clinical use to support root cause resolution. In coordination with the department supervisor, manager, and escalation teams, strategize to ensure customer satisfaction. Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments. Experience:
5+ years of medical device experience, preferably in a regulatory or technical complaint investigation capacity. 2+ years of experience with medical device complaint handling, post-market surveillance, or in a similar regulated environment. Working knowledge of QA and regulatory or quality compliance in the medical device industry preferred. Experience with infusion pumps and disposable tubing equipment is desired but not required. Skills:
Critical thinking skills. Ability to solve problems and meet multiple deadlines in a fast-paced environment. Excellent writing skills and knowledge of good documentation practices. Ability to work on multiple projects with various disciplines. Adaptability in an ever-changing environment. Ability to work in a complaint investigation laboratory environment containing hazardous materials. Proficient in Microsoft Word, PowerPoint, and Excel. Ability to read, analyze, and interpret scientific and technical journals and legal documents. Ability to respond to inquiries or complaints from customers, regulatory agencies, or business stakeholders. Ability to effectively present information to management, departments, and customers. Ability to apply clinical and technical skills to regulatory functions. Provide support for internal quality audits of complaint files and MDR documentation, and external audits or inspections. Strong organizational skills and flexibility to manage competing priorities and task volume. Qualification And Education:
Bachelor's degree in a related field is desirable.
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Pay Range: $51.72hr - $53.79hr
Responsibilities:
Conduct product complaint investigations and write failure investigation reports. Ensure accuracy for complaint file documentation and regulatory reporting decision activities. Ensure timely follow-up with customers and company representatives for reported issues. Ensure complaint files are accurate and complete, and in line with good documentation practices. Assist regulatory reporting activities to ensure medical device reports are submitted within required timeframes and company policy. Demonstrate sound independent decision-making in regard to medical device reporting and other functions relating to the investigation of product complaints. Provide or facilitate clinical expertise and troubleshooting for customers as appropriate. Collaborate with supervisor, manager, and/or department RNs to assess the severity of complaints and understand typical clinical use to support root cause resolution. In coordination with the department supervisor, manager, and escalation teams, strategize to ensure customer satisfaction. Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments. Experience:
5+ years of medical device experience, preferably in a regulatory or technical complaint investigation capacity. 2+ years of experience with medical device complaint handling, post-market surveillance, or in a similar regulated environment. Working knowledge of QA and regulatory or quality compliance in the medical device industry preferred. Experience with infusion pumps and disposable tubing equipment is desired but not required. Skills:
Critical thinking skills. Ability to solve problems and meet multiple deadlines in a fast-paced environment. Excellent writing skills and knowledge of good documentation practices. Ability to work on multiple projects with various disciplines. Adaptability in an ever-changing environment. Ability to work in a complaint investigation laboratory environment containing hazardous materials. Proficient in Microsoft Word, PowerPoint, and Excel. Ability to read, analyze, and interpret scientific and technical journals and legal documents. Ability to respond to inquiries or complaints from customers, regulatory agencies, or business stakeholders. Ability to effectively present information to management, departments, and customers. Ability to apply clinical and technical skills to regulatory functions. Provide support for internal quality audits of complaint files and MDR documentation, and external audits or inspections. Strong organizational skills and flexibility to manage competing priorities and task volume. Qualification And Education:
Bachelor's degree in a related field is desirable.
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