Complaint Vigilance Investigator II

Position Title: Complaint Vigilance Investigator II Department: QA

Reports To: Director, Complaint Viglance FLSA : Exempt

GENERAL SUMMARY

As a Complaint Vigilance Investigator II, you will play a pivotal role in the complaint handling process. Your responsibilities will encompass all stages of the complaint lifecycle, from feedback review to the completion of regulatory decision trees, with focus on complaint investigation and regulatory reporting. This position works closely with the Service, Customer Service, Quality, Regulatory and Engineering Teams.

ESSENTIAL JOB FUNCTIONS

• Review and analyze all feedback and assess if a complaint is alleged.
• Triage customer feedback or questions and initiate complaints into the database.
• Execute initial complaint review to ensure accurate codes are assigned, GFE are initiated, and intake has been properly performed.
• Conduct thorough investigations into customer complaints, adhering to regulatory guidelines.
• Perform final complaint review to ensure all requirements to investigate a complaint are met.
• Provide feedback to improve Complaint and MDR processes.
• Collaborate with Customer Service and Operations teams to facilitate the complaint handling process.
• Reach out to the complainant to obtain missing information (GFE’s) needed for the complaint investigation and/or MDR processes. Provide customer response letters when requested.
• Initiate and process MDR filings for the FDA, demonstrating a comprehensive understanding of regulatory requirements. Attend MDR review meetings for coding and narrative guidance on MDRs.
• Document all stages of customer complaints, maintaining accurate records for compliance purposes.
• Applies analytical skills and product knowledge to evaluate complex situations using multiple sources of information
• Escalation to Management of potential safety issues or issues that could impede the ability to process complaints and close records.

OTHER DUTIES AND RESPONSIBILITIES

• Support process improvements to the complaint handling and MDR processes
• Support metric and reports from the complaint handling system
• Identifies potential concerns and escalates to management when necessary
• Provides support of CAPAs and NC’s as necessary
• Train to all assigned SOP’s, WI and templates/forms
• Additional responsibilities may or may not be assigned to the employee; role assignment will be reviewed on a case-by-case basis determinant upon individual strengths, experience, knowledge, and expertise.

PREPARATION, KNOWLEDGE, SKILLS & ABILITIES

• Associates degree or equivalent experience. Bachelor’s degree a plus
• Minimum 2-4 years complaint handling experience required: Preferred in the FDA-regulated environment for Medical Device industry.
• Accuracy, attention to detail, and thoroughness required
• Ability to learn the basic operation and testing procedures for infusion products
• Knowledge of 21CFR 820 Quality System Regulations and familiarity with MDR filing processes and requirements for the FDA as per 21CFR820 and 21CFR803.
• Strong communication and data analysis skills.
• Team player as well as an individual contributor that can work independently to achieve goals.