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Complaint Manager Location: San Diego Duration: 1 year, possibility for extension and conversion to direct. Pay: $43-$47 an hour
Duties & Responsibilities
• Conduct product complaint investigations and write failure investigation reports
• Ensure accuracy for complaint file documentation and regulatory reporting decision activities.
• Ensure complaint files are accurate and complete and in line with good documentation practices.
• Demonstrate sound independent decision making in regard to medical device complaint handling and other functions relating to the investigation of product complaints. Asks questions of team leaders / management as needed.
• Provide or facilitate clinical expertise/troubleshooting for customers as appropriate.
• Collaborate with supervisor, manager to assess the severity of complaints and understand the typical use to provide input to the Technical investigation for optimal root cause resolution as needed.
• Handle product for investigation per quality system requirements
• In concert with the department supervisor and/or manager and escalation teams, strategize to direct the efforts to ensure Dispensing customer satisfaction.
• Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
• Ensure timely follow-up with internal customers and company representatives for reported issues.
Qualifications:
• Bachelors degree in related field is desirable
• 3-5 years of medical device experience is desired, preferably in a regulatory or technical complaint investigation capacity.
• 2+ years of experience with medical device complaint handling / post-market surveillance / medical device regulations or experience in a similar regulated environment preferred. Working knowledge of QA, Regulatory/Quality Compliance in a medical device industry preferred.
• Knowledge of electronics is preferred,
Knowledge, Skills & Abilities
• Critical thinking skills.
• Ability to solve problems and to meet multiple deadlines within a fast-paced environment.
• Excellent writing skills, knowledgeable of good documentation practices.
• Ability to work on multiple projects with various disciplines.
• Ability to adapt quickly in an ever-changing environment
• Ability to work in a complaint investigation laboratory environment containing hazardous materials
• Able to utilize computers for development of reports and summary of project experience including word processing and spreadsheet computer applications such as Microsoft Word, PowerPoint and Excel.
• Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community.
• Ability to effectively present information to management, ancillary departments, and/or customers.
• Ability to apply technical skills to regulatory functions.
• Provide support for internal quality audits of complaint files, as well as external audits/inspections from Regulatory Bodies as requested.
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