Title: Complaint Management Specialist III

Location: San Diego, CA

Note: This is a W2 contract role – 1099, C2C, and 3 ^rd party candidates will NOT be considered

The Sr. Complaint Specialist Customer Advocacy role is responsible for medical device post-market surveillance as it relates to complaint handling functions. This role is responsible for the completion of all tasks associated with complaint handling, including the investigation of failed product, working with hazardous materials in controlled lab environment, writing clear and effective failure investigation reports, reviewing reported events in the complaints database for trending and optimal root cause identification, and managing process failed components within the proper workflow. Additionally, this role will provide technical expertise and troubleshooting support for internal and external customers, as requested.

Position 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, complete, and in-line with good documentation practices
• Assist with regulatory reporting activities to ensure medical device reports are submitted within FDA and Health Canada timeframes and company policies
• Receive failed components and properly track them through the investigation process, from receipt to investigation to disposition
• Accurately handle failed components and package tracking through multiple sites
• Demonstrate sound independent decision making in regard to medical device reporting and other functions related to the investigation of product complaints; asks questions of team leaders / management, as needed
• Collaborate with supervisors and/or managers to assess the severity of complaints and understand the typical clinical use to provide input to the technical investigation for optimal root cause resolution, as needed
• Ensure timely follow-up with customers and company representatives for reported issues

Position Qualifications:

• 3+ 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 / medical device regulations, or experience in a similar regulated environment preferred
• Strong critical thinking skills
• Ability to solve problems and to meet multiple deadlines within a fast-paced environment
• Excellent writing skills, including 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
• Ability to utilize computers for development of reports and summaries of project experience, including word processing and spreadsheet computer applications, such as Microsoft Word, PowerPoint, and Excel
• Ability to read, analyze, and interpret common scientific, technical journals, and legal documents
• Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community
• Flexibility and excellent organizational skills to manage/adapt to competing priorities and volume of tasks
• Working knowledge of QA, regulatory/quality compliance in a medical device industry preferred
• Knowledge of electronics engineering preferred
• Bachelor’s Degree in Clinical Science, Engineering, or other relevant field

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