Product Quality Complaint Specialist

Job Description

Job Description

Product Quality Complaint Specialist 
Bridgewater, NJ - Hybrid 3 days a week onsite 
Pay: $41.00 - $44.00 per hour 
26-09333
Position Overview

The Product Quality Complaint Specialist is responsible for the daily management of commercial product quality complaints, including complaint intake, file creation, review, investigation coordination, trend identification, metric tracking, and timely complaint closure. This role ensures complaints are processed in accordance with applicable quality procedures, global regulations, and product quality standards while identifying and escalating potential product performance, quality, and safety concerns. The ideal candidate has strong organizational, analytical, problem-solving, and communication skills and can effectively collaborate with technical and non-technical stakeholders across multiple functions.

Job Responsibilities

• Capture, review, analyze, and document product quality complaints.
• Create and maintain complaint files and ensure complaint records are processed and closed in a timely manner.
• Communicate directly with customers by phone and email to gather and clarify complaint information.
• Identify and document customer feedback related to products, services, and business processes.
• Ensure complaint activities comply with applicable global product quality guidelines, standards, regulations, and documented procedures.
• Differentiate between product quality complaints, adverse events or incidents, medical information requests, customer feedback, and regulatory agency requests.
• Collaborate with field personnel, Quality, Engineering, Operations, and other internal teams to process complaints efficiently.
• Initiate, coordinate, review, and summarize complaint investigations.
• Perform product return evaluations as required.
• Identify trends and potential product performance issues and communicate concerns to appropriate stakeholders.
• Escalate product quality and safety concerns reported or experienced by customers.
• Track complaint processing metrics and identify opportunities to improve complaint management processes.
• Work collaboratively with Research and Development, Engineering, Marketing, Medical Affairs, Technical Service, Customer Care, and other departments.
• Provide support during internal and external audits and regulatory inspections as required.
• Perform other duties as assigned.

Job Requirements

• 0-2 years of relevant experience in a medical device, biologics, pharmaceutical, or other regulated life sciences organization is preferred.
• Experience working in a regulated cGMP environment is preferred.
• Bachelor's degree is required.
• Bachelor's degree in Science, Mathematics, Engineering, or a related technical field is preferred.
• Knowledge of product complaint management processes is preferred.
• Knowledge of applicable regulations and quality standards related to complaint management is preferred.
• Familiarity with regulations and standards such as 21 CFR Part 820, 21 CFR Part 803, 21 CFR Parts 210/211, ISO 13485, MDSAP, and EU MDR is preferred.
• Demonstrated organizational, analytical, problem-solving, and time management skills.
• Excellent interpersonal, written, and verbal communication skills.
• Ability to follow documented procedures and established quality processes.
• Ability to interact effectively with technical and non-technical personnel at all organizational levels.
• Ability to read and understand technical documentation, including investigations and service orders.
• Ability to understand device, drug, and/or biologic operational activities is preferred.

Technical Skills

• Microsoft Office, including Excel, Word, and PowerPoint.
• Ability to learn and effectively use database and complaint management software.
• Product complaint intake, review, investigation, and documentation.
• Complaint trend analysis and metric tracking.
• Quality and regulatory compliance.
• Technical documentation review.

Additional Job Details (Commute, Attendance, etc.)

• Hybrid schedule requiring onsite work three days per week: Tuesday, Wednesday, and Thursday.
• Standard work schedule is Monday through Friday, 9:00 AM to 5:00 PM.
• This position works primarily in an office environment.
• Extended periods of sitting are required.
• Daily use of a computer and telephone is required.