Complaint Management Specialist - Urgent Need

Job Description Summary

The Sr. Complaint Specialist Customer Advocacy role is responsible for medical device post-market surveillance as it relates to complaint handling functions. The role involves investigation of failed products, working with hazardous materials in a controlled lab environment, writing clear and effective failure investigation reports, reviewing reported events in the complaints database for trends and optimal root cause identification, and managing failed components within the proper workflow.

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. - Assist in regulatory reporting activities to ensure medical device reports are submitted within FDA and Health Canada timeframes and company policy. - 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 relating to the investigation of product complaints. Ask questions of team leaders / management as needed. - Collaborate with supervisor and/or manager 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.

Qualifications

Education & Experience

- Bachelor’s degree in related field is desirable. - 3+ 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 read, analyze, and interpret common scientific and 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.