Junior Quality Assurance Specialist

Junior 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.

#ZR

About Equiliem

Equiliem believes in empowering success. It's our job to cultivate relationships that connect people and employers in a way that is inclusive, intelligent, and allows both to thrive.

Across the U.S., leading companies in healthcare, government, engineering, manufacturing, professional services, and energy rely on us for their workforce solutions. Our recruiting and HR services include contract and direct hire staffing, Payrolling/EOR, Independent Contractor Compliance, and Managed Services.

For almost 30 years, we've helped shape our industry. Today, we continue to research, ask questions, and continuously enhance the candidate journey and client experience.

Benefits

We offer a comprehensive benefits package to our employees, which includes:

• Medical Insurance
• Vision & Dental Insurance
• Life Insurance
• Matching 401(k)
• Commuter Benefits
• Employee Discounts & Rewards
• Payroll Payment Options

By applying, you are providing consent for Equiliem to engage with you via phone calls, AI-generated calls, AI-generated text messages, standard text messages, and/or emails to share job opportunities. Consistent with our Privacy Policy, information obtained will not be shared with third parties for marketing or promotional purposes. Message frequency may vary for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You may reply STOP to cancel or HELP for assistance.

Equiliem is an equal opportunity employer. We do not discriminate or allow discrimination based on race, color, religion, creed, sex, age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Equiliem will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at [emailprotected] or (732) 238-6050.