Junior Quality Assurance Specialist

Job Summary

The Junior Quality Assurance Specialist is responsible for supporting the daily management of commercial product quality complaints by ensuring timely intake, investigation, documentation, and resolution of customer-reported product issues. This role works closely with cross-functional teams to evaluate complaints, identify trends, support regulatory compliance, and maintain accurate quality records. The ideal candidate is detail-oriented, analytical, and interested in building a career within a regulated quality environment.

Job Responsibilities

• Receive, review, document, and analyze product quality complaints.
• Create and maintain complaint files while ensuring timely processing and closure.
• Communicate with customers via phone and email regarding product quality concerns.
• Identify and document customer feedback related to products, services, and processes.
• Support complaint investigations by initiating, coordinating, reviewing, and summarizing findings.
• Evaluate returned products when required to support complaint investigations.
• Monitor complaint trends and report potential product performance or quality issues to management.
• Escalate quality and safety concerns in accordance with established procedures.
• Differentiate between product quality complaints, adverse events, medical information requests, customer feedback, and regulatory inquiries.
• Collaborate with Quality, Engineering, Operations, Field Personnel, Technical Services, Customer Care, Medical Affairs, Marketing, and Research & Development teams to resolve complaints.
• Ensure compliance with applicable quality systems, regulatory requirements, and documented procedures.
• Support internal audits, external audits, and regulatory inspections as needed.
• Perform additional duties as assigned.

Job Requirements

• Bachelor's degree required; Science, Engineering, Mathematics, or a related technical field preferred.
• 0–2 years of experience in a medical device, pharmaceutical, biologics, or other regulated manufacturing environment preferred.
• Experience working in a cGMP-regulated environment preferred.
• Familiarity with quality systems and regulatory standards such as FDA 21 CFR Parts 820, 803, 210/211, ISO 13485, MDSAP, EU MDR, or similar regulations preferred.
• Strong organizational, analytical, problem-solving, and time management skills.
• Proficiency with Microsoft Office, including Excel, Word, and PowerPoint.
• Ability to learn and utilize quality management databases and software.
• Ability to read and interpret technical documentation, investigations, and service records.
• Strong written and verbal communication skills with the ability to interact effectively with technical and non-technical personnel.
• Ability to follow documented procedures while maintaining a high level of accuracy and attention to detail.

Education

• Bachelor's degree required.
• Degree in Science, Engineering, Mathematics, or a related field preferred.