Complaints Handler

Covington, Georgia (Hybrid – 4 days onsite Monday through Thursday; remote on Friday)

Contract

12 Months (with potential for extension based on business needs)

This is a contract position. Employer-provided benefits are not included unless otherwise specified by the staffing agency or required by applicable law.

The FA Specialist I is responsible for receiving, documenting, investigating, reviewing, and closing customer product complaints for medical devices in accordance with company policies, FDA regulations, Quality System Regulations (QSR), Good Manufacturing Practices (GMP), and applicable quality standards. This role works closely with customers, sales representatives, legal, clinical risk, and quality teams to ensure complaint files are complete, accurate, and processed in a timely manner.

The position requires strong attention to detail, excellent communication skills, and the ability to manage multiple priorities in a regulated environment.

• Receive, document, and process customer product complaints in accordance with established procedures.
• Review complaint documentation for accuracy, completeness, and regulatory compliance.
• Contact customers, hospitals, distributors, or sales representatives to obtain additional information when necessary.
• Request and coordinate the return of complaint samples for evaluation.
• Maintain complaint files and ensure documentation meets quality and regulatory requirements.
• Review complaint files for Medical Device Reporting (MDR) and vigilance considerations.
• Draft MDR documentation for review by Clinical Risk Specialists.
• Perform final quality review of complaint files prior to closure.
• Utilize complaint management software such as Track Wise or similar systems.
• Provide complaint-related documentation to internal legal teams when required.
• Maintain accurate records using Good Documentation Practices (GDP).
• Collaborate effectively with cross‑functional teams including Quality, Regulatory Affairs, Clinical Risk, Customer Service, and Legal.
• Support continuous improvement initiatives related to complaint handling processes.

• High school diploma or equivalent required.
• Associate's or Bachelor's degree is preferred.
• Minimum of two (2) years of experience in an FDA-regulated or similarly regulated industry.
• At least one (1) year of experience in medical device, pharmaceutical, or comparable complaint handling is preferred.
• Minimum of one (1) year of customer service experience.
• Working knowledge of FDA regulations, Quality System Regulations (QSR), Good Manufacturing Practices (GMP), and applicable quality standards.
• Experience with complaint management software such as Track Wise or similar systems is preferred.
• Proficiency with Microsoft Word and Microsoft Excel.
• Strong written and verbal communication skills.
• Excellent organizational skills and attention to detail.
• Ability to draft professional correspondence with customers and healthcare facilities.
• Ability to manage multiple priorities while maintaining accuracy.
• Strong interpersonal and problem‑solving skills.
• Ability to work effectively both independently and as part of a collaborative team.

• Hybrid work schedule with onsite attendance Monday through Thursday and remote work on Friday.
• Ability to work in a professional office environment.
• Regular use of computers, telephones, and standard office equipment.
• Ability to sit, stand, walk, and communicate throughout the workday.
• Occasional lifting of materials weighing up to 25 pounds, with reasonable accommodations provided where required by applicable law.