Job Description
Job DescriptionJunior Quality Assurance Specialist
Bridgewater, NJ
Pay: $41.00 - $45.00 per hour
26-07357
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.
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