Product Complaint Coordinator

Overview

The Complaint Coordinator is responsible for managing the Quality Affairs/Regulatory Affairs (QA/RA) queue.

Responsibilities

Administer case database with particular focus on product complaints

• Maintain integrity of cases and the complaint management process
• Report on designated case metrics at defined intervals
• Provide case analyses as requested by management
• Interface with various departments using case systems      

Complaint Management              

• Review assigned cases within the QA/RA queue daily
• Audit relevant case information and update required fields where necessary
• Initiate communication and interaction cross-functionally regarding product complaints  
• Ensure all complaints are acknowledged and completed within the given timeframe
• Perform regulatory closure of product complaint cases
• Identify complaints that require escalation as a potential reportable event based on established criteria and applicable regulations and notify management within specified timeframe
• Assist with complaint related reporting activities
• Assist with preparation of required reports, e.g. MDR’s, to external agencies
• Support departmental audits/reviews of conformance to applicable standards
• Other duties as assigned

Qualifications

Education & Experience

Required:

• Bachelor’s degree or equivalent work experience
• 1 years’ experience handling customer complaints from receipt to closure, in regulated medical device industry

Preferred:

• Previous regulatory or quality experience
• Experience analyzing medical device complaints and reporting on adverse events

 Knowledge & Skills

• Strong proficiency in Microsoft Office Suite, including Word, Excel, Teams and PowerPoint
• Ability to successfully manage multiple tasks at one time
• Ability to utilize data from metrics and key data points
• Familiarity with federal regulatory compliance
• Understanding of the business and products (Department processes and overall objectives)
• Ability to work independently and amongst a team
• Ability to communicate effectively with employees at all levels of the business
• Strong problem solving and critical thinking skills
• High attention to detail and accuracy
• Ability to organize and plan activities that drive and meet deadlines
• Working knowledge of Filemaker and NetSuite Database structures or equivalent

Competencies

• Critical Thinking
• Problem Solving
• Organization
• Communication
• Detail Oriented
• Analytical
• Teamwork
• Process Oriented

Below is the salary range for this position, although offers may differ based on the candidate’s location, job-specific knowledge, skills, and experience.

$23.41 - $35.10 / HR

Additional benefits:

Non-Exempt - Our total compensation package includes medical, dental and vision benefits, retirement benefits, employee stock purchase plan, paid time off, parental leave, family medical leave, volunteer time off and additional leave programs, life insurance, disability coverage, and other life and work wellness benefits and discounts. Benefits may be subject to generally applicable eligibility, waiting period, contributions, and other requirements and conditions.

Salary : $23 - $35