RQM+ is hiring a
Complaint Specialist

Summary

Join RQM+ as a Complaint Consultant, supporting the investigation process for product design and process related complaints for Post-Market Medical Device and Combination Products. Responsibilities include conducting post-market surveillance activities, ensuring complaint containment reports are run, performing appropriate evaluation steps, and managing multiple cases in parallel.

Requirements

• Minimum of 2 years of experience in Medical Device Complaint Handling
• Medical device engineering experience
• Knowledge and understanding of end-to-end device complaint handling process including Adverse Event Reporting to US FDA (MDR) and OUS Regulators
• Experience completing device complaint investigations and reportability determinations
• Excellent written and verbal communication
• Ability to manage multiple cases in parallel to ensure timely completion of activities
• Understands and complies with all current cGMP and QSR requirements as defined by management our/or outlined in standard operating procedures as well as recording necessary documentation to comply with various regulatory agencies

Responsibilities

• Conducts post-market surveillance activities including complaint/MDR handling
• Ensures complaint containment reports are run as required procedures, and coordinates activities to resolve issues that appear on the reports
• Ensures complaint meets department requirements
• Performs appropriate evaluation steps to ensure all available information is present so that team can determine reportability
• When necessary, performs remediation activities on complaint files to bring them up to standard
• Will need to be able to evaluate complaint files that have been identified as being filed late with the reporting agency for an Adverse Event
• Reviews intake source systems, complaint handling databases, and other systems to determine chain of events in the complaint process
• Coordinates the report assignments to ensure activities are completed in a timely manner and escalates issues to the appropriate department for resolution if required
• Responsible for completing work activities, as defined by the project lead, on schedule and in accordance with the allotted hours
• Communicates project risk and issues to the project lead in a timely fashion

Preferred Qualifications

• Experience with Combination products is a plus
• Experience working Trackwise and Argus is a plus
• Able to clearly explain and present technical information within and outside of the organization (i.e. technical resource to 3rd Party vendors, medical personnel, marketing, service publications, training, R&D, etc.)

Benefits

• Providing a rewarding place to work is rooted deep in our core values
• From an industry leading compensation package to a deeply engrained focus on work life balance, RQM+ has a unique offering for regulatory and quality professionals