Quality Assurance (Complaint handling)

Position Title: Quality Assurance (Complaint handling)

Location: Austin, TX, 78727

Type: Hybrid (3 Days Onsite / 2 Days Remote)

Duration: 1 Year (Potential Extension)

Schedule: Monday-Friday, 8:30 AM - 5:00 PM

Position Summary:

This position is part of the organization's Global Quality Organization, responsible for processing pharmaceutical, medical device, and combination product complaints and inquiries. The role involves interfacing with internal stakeholders, including physicians, nurses, pharmacists, hospital personnel, sales representatives, and manufacturing sites-to ensure high-quality complaint documentation, investigations, and regulatory compliance.

Key Responsibilities:

• Ensure complaint records meet global regulatory requirements and Good Documentation Practices.
• Document, investigate, and review non-medical complaint content; review medical complaints involving non-medical quality issues.
• Coordinate return samples and follow-up activities (e.g., product replacement) to support quality customer service.
• Identify potentially reportable events and notify appropriate internal stakeholders and management.
• Prepare and submit regulatory reports and customer communications.
• Interface with third-party manufacturers, healthcare professionals, internal teams, and regulatory agencies.
• Maintain complaint files in accordance with FDA regulations and internal SOPs.

Required Qualifications:

• Bachelor's degree required (preferred in a scientific or technical field such as MLT, LPN, or RN).
• 0-3 years of experience in a cGMP-regulated industry or clinical setting preferred.
• Knowledge of global regulatory requirements related to pharmaceuticals, medical devices, and combination products.
• Understanding of FDA Quality Systems and Medical Device Reporting regulations (21 CFR 803, 820, 211) is preferred.
• Ability to prioritize multiple projects while maintaining compliance with SOPs and regulations.
• Strong analytical, technical writing, and organizational skills.
• Proficiency in computer systems used for word processing and complaint management.
• Ability to collaborate with cross-functional teams and communicate effectively with internal and external stakeholders.

Top Required Skills:

1. Quality Assurance experience
2. Organizational skills and attention to detail
3. Critical thinking and problem-solving
4. Adaptability in a dynamic environment
5. Experience in medical/pharmaceutical settings (preferred)