QA Complaint Intake Specialist /Associate

Job Title: QA Complaint Intake Specialist / Associate
Duration: 3 Months (12 weeks) No extension
Hybrid Schedule - 4 days onsite mandatory

Purpose:
The QA Complaint Intake Specialist / QA Complaint Triage Associate is responsible for supporting the intake, triage, documentation, follow-up, and verification of medical device complaints associated with the iovera product line. This role ensures complaint information is accurately captured within the electronic Quality Management System (eQMS), required information is obtained and documented, and complaint records are prepared for evaluation by the assigned QA Complaint Investigator.

Responsibilities:

1. Receive complaint information from approved intake sources including Customer Support, field personnel, sales representatives, Medical Affairs, email communications, phone calls, and other authorized channels.

2. Review incoming complaint information and supporting documentation to assess reported events, identify potential complaint criteria, and initiate required follow-up activities.

3. Accurately document complaint information within the complaint handling module/eQMS, including but not limited to:
Problem statement and event description
Device and product configuration information
Lot, serial, or batch number
Patient impact and medical intervention details
Event and awareness dates
Reporter/contact information
Returned product status
Supporting documentation and attachments

4. Perform initial complaint triage activities to assess completeness of available information, identify missing or unclear details, and determine the need for additional follow-up or escalation.

5. Support initial reportability screening activities by collecting and documenting information related to:
Device malfunction or failure mode
Seriousness and recurrence of the event
Patient outcome and medical intervention
Device availability for evaluation
Potential regulatory reporting considerations
6. Coordinate and document follow-up activities with internal and external stakeholders to obtain missing, incomplete, or clarifying information necessary for complaint assessment and investigation.

7. Request, track, and document follow-up information including:
Exact event date and time
Error codes and system/banner messages
Treatment status and patient impact
Troubleshooting activities performed
Device usage status and return availability
Photographs, screenshots, log files, and supporting evidence

8. Track and document follow-up attempts, stakeholder responses, unresolved information gaps, and escalation activities within the complaint record.

9. Support verification and record review activities, including:
Device History Record (DHR) review
Product identity and configuration verification
Lot/serial number confirmation
Shipment and distribution review
Returned product status tracking
Functional testing request status
Field log/logfile availability and retrieval

10. Coordinate returned product retrieval and log file collection activities, when applicable, and document device status, location, chain of custody, and evaluation availability.

11. Create and maintain complete, accurate, and compliant complaint files in accordance with internal procedures, FDA regulations, ISO 13485, EU MDR, and applicable regulatory requirements.

12. Escalate potentially serious, reportable, recurring, urgent, or incomplete complaint events to QA Management and/or the assigned Complaint Investigator in a timely manner.

13. Ensure complaint intake, triage, documentation, follow-up, and verification activities are completed within established quality system and regulatory timelines.

14. Provide complaint intake metrics, aging reports, follow-up status, and triage-related information to support complaint trending, post-market surveillance, management review, audits, inspections, and continuous improvement activities.

15. Support additional complaint handling, quality system, and post-market surveillance activities as assigned.


Supervisory Responsibilities:
This person has no direct supervisor responsibilities.

Education and Experience:
Minimum 13 years of relevant experience in Quality Assurance, medical device/pharmaceutical documentation, customer support, or another regulated industry preferred. Medical device or pharmaceutical experience is preferred. BS/BA degree in a scientific, technical, healthcare, or quality-related discipline is desirable; equivalent experience may be considered. Experience with eQMS, complaint handling systems, or regulated documentation is preferred.

Knowledge, Skills, and Abilities:

• The individual should have a basic understanding of medical device and quality system requirements; strong organizational skills; strong attention to detail; ability to accurately review and document information; ability to determine the number of complaint events from emails and supporting communications; ability to identify missing or unclear information; ability to coordinate timely follow-up; good written, verbal, and interpersonal communication skills; ability to work professorially with cross-functionally teams, Complainant, Customer Support, Field Sales, Medical Affairs, QA, Operations, and Complaint Investigators; ability to manage multiple complaint records within required timelines; and working knowledge of Microsoft Word, Excel, Outlook, and eQMS systems.

• The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
• Typical office setting, cubicles, noise level is moderate with consistent printer, telephone ringing and conversation. The work environment also includes warehouse and manufacturing areas.

• The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
• While performing the duties of this job, the employee is regularly required to sit, talk, move between spaces, reach with hands and arms and stoop. Close vision and the need to focus on computer screen, use of hands, fingers and wrist to type on keyboard and manipulate mouse.