What are the responsibilities and job description for the Complaint Coordinator position at C4 Technical Services?
Job Description
The Complaint Coordinator is responsible for managing the Quality Affairs/Regulatory Affairs (QA/RA) case queue by performing the roles as described herein.
Responsibilities:
Administer case (formerly Field Experience Reports) database with particular focus on product complaints and support post market surveillance objectives
- 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
- Follow established post market surveillance processes
- 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
- Provide feedback on the complaint process and coding when needed to ensure consistency and clarity
- Participate in cross-functional activities throughout the complaint process, e.g. clinical case review meetings
- Support actions required to resolve complaint trends, e.g. CAPA-related tasks, as needed
- 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
Job Types: Full-time, Contract
Pay: $25.00 - $28.00 per hour
Expected hours: 40 per week
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Flexible schedule
- Health insurance
- Paid time off
- Vision insurance
Shift:
- Day shift
- Morning shift
Work Location: In person
Salary : $25 - $28
