QARA Complaints Specialist - Braselton, GA

Job Summary

We are seeking a detail-oriented and highly motivated QARA Complaint Specialist to join our Wellspect team. This position plays a key role in ensuring timely and accurate disposition, intake and documentation of product complaints, including the determination and distinction between service, product preference and product complaints. This role supports regulatory compliance and collaborates across functions to enhance product quality and customer satisfaction. The ideal candidate brings a strong sense of accountability, excellent communication skills, and a desire to grow within the medical device industry.

Responsibilities

• Complaint Intake and Documentation
• Serves as the primary complaint initiator for the Wellspect US Complaint Handling team.
• Receives, evaluates, codifies, and documents product complaints accurately in the designated complaint management system, ensuring all required data is captured in a timely and compliant manner.
• Customer Communication
• Conducts follow-up communication with complainants to support complaint investigations and gather additional information as needed.
• Provides regular updates on complaint status and, when applicable, communicates final investigation findings to the complainant in a professional and empathetic manner.
• Compliance
• Ensures all complaint-handling activities are performed in accordance with applicable US regulations and standards, including but not limited to 21 CFR 820, 21 CFR 803, ISO 13485:2016, etc.
• Adheres to internal policies, SOPs, and quality system requirements.
• Complaint Investigation Support
• Contributes to the investigation process by collaborating with internal teams and supporting documentation efforts.
• Participates in root cause analysis and recommend next steps as appropriate.
• CAPA
• Supports the implementation of corrective or preventive actions stemming from complaint data, helping to reduce the likelihood of recurrence.
• Reporting and Trending
• Prepares reports and contributes data insights to support ongoing quality improvement initiatives.
• Training and Knowledge Sharing
• Provides guidance and shares best practices with internal teams on complaint handling processes.
• Supports onboarding and training of new team members as needed.
• Cross-Functional Collaboration
• Partners with teams such as Engineering, Manufacturing, Regulatory Affairs, Field Sales Call Center Operations and Customer Service to resolve complaints effectively and drive continuous improvement.

Education

• Bachelor’s degree in a scientific, technical, or healthcare-related discipline required.

Experience

• 3+ years of experience in a customer-facing or highly regulated role preferred.
• Experience in a medical device, pharmaceutical, or other life sciences industry is a strong plus.

Key Skills, Knowledge, and Capabilities

• Proficient in English; strong written and verbal communication skills required.
• Multilingual abilities are highly desirable.
• Excellent organizational skills and a high degree of attention to detail are fundamental to success.
• Strong comfort level with computer-based tasks, including working across multiple systems or screens simultaneously.
• Proficiency in standard office software (e.g., Microsoft Office Suite); experience with electronic quality or complaint management systems preferred.
• Able to work both independently and collaboratively in a fast-paced, team-oriented environment.
• Familiarity with regulated environments and an understanding of global regulatory frameworks preferred.
• Occasional travel may be required (