Quality & Compliance Specialist - Complaints

Mon-Fri, 8:30am - 5:00pm

Pay: $25-$30/hr BOE

General Description:

The Associate Complaint Management Specialist Level 2 is responsible for managing all aspects of medical device complaint reporting, investigation, and resolution, ensuring compliance with applicable laws and regulations. This role includes the duties of a Level 1 specialist and additional leadership, analysis, and process improvement responsibilities.

Key Responsibilities:

• Complaint Management (Level 1 & Level 2 duties):

  • Record, evaluate, and process complaint submissions, ensuring timely resolution.
  • Communicate with internal teams (territory managers, clinical specialists, Customer Service, Regulatory Affairs, Quality Assurance, Manufacturing, R&D) to gather necessary information.
  • Provide regulatory reportability decisions on complaints and generate required reports to authorities.
  • Respond to inquiries regarding medical device report submissions related to device malfunctions or injuries.
  • Manage returned goods and perform decontamination if necessary.
  • Participate in audits, inspections, and cross-functional projects.
  • Review and close complaint files, ensuring all documentation is complete.

• Leadership & Analysis (Level 2 added duties):

  • Lead weekly internal department meetings and provide complaint report analysis to identify trends.
  • Prepare and submit final customer correspondence as needed.
  • Review and ensure accurate preparation of complaint files for closure.
  • Support audit preparation and ensure compliance with regulatory requirements.
  • Serve as a subject matter expert on complaint management and device reporting processes.
  • Coordinate with cross-functional teams to ensure thorough investigations and timely resolution of complex complaints.

Position Qualifications:

• Knowledge of medical device reporting regulations and medical terms related to sacral neuromodulation procedures.
• Strong analytical, organizational, and communication skills.
• Ability to manage multiple priorities independently and efficiently in a fast-paced environment.
• Positive, flexible attitude toward new processes and change.

Education & Experience:

• Bachelor’s degree preferred.
• Minimum of 3 years of relevant work experience, with prior experience as a Complaint Specialist Level 1 (CSI) preferred.