Quality Assurance Specialist

Quality Assurance Specialist

Location: Bridgewater, NJ (Hybrid)

Employment Type: Onsite

Pay Range: $40-44/hr on W2

Position Summary

The Quality Assurance Specialist (Junior) is responsible for the daily management of commercial Product Quality Complaints to ensure timely and compliant complaint handling. This role supports complaint intake, investigation, documentation, trend analysis, and closure while maintaining compliance with applicable FDA, ISO, and global quality regulations. The ideal candidate is detail-oriented, analytical, and eager to build a career in Quality Assurance within the medical device, pharmaceutical, or biologics industry.

Key Responsibilities

• Capture, review, analyze, and document product quality complaints.
• Create and maintain complaint files within the quality management system.
• Communicate directly with customers via phone and email regarding product complaints.
• Identify customer feedback related to products, services, and business processes.
• Ensure complaint handling complies with applicable global quality regulations and internal procedures.
• Differentiate between:
• Product Quality Complaints
• Adverse Events/Incidents
• Medical Information Requests
• Customer Feedback
• Regulatory Agency Requests
• Coordinate with Quality, Engineering, Operations, and Field Personnel to ensure timely complaint investigations.
• Initiate, review, summarize, and document complaint investigations.
• Perform product return evaluations when required.
• Monitor complaint trends and identify potential product performance issues.
• Escalate quality and safety concerns to appropriate management.
• Collaborate with cross-functional teams including:
• Research & Development
• Engineering
• Marketing
• Medical Affairs
• Technical Services
• Customer Care
• Support internal audits and regulatory inspections.
• Complete additional quality-related assignments as needed.

Required Qualifications

• Bachelor's degree required.
• Degree in Science, Engineering, Biology, Chemistry, Biomedical Engineering, Mathematics, or a related technical discipline preferred.
• 0–2 years of experience in:
• Medical Device
• Pharmaceutical
• Biologics
• Life Sciences
• Regulated Manufacturing
• Internship, co-op, or academic laboratory experience is acceptable for entry-level candidates.

Preferred Qualifications

• Experience working in a regulated cGMP environment.
• Basic understanding of complaint handling and quality systems.
• Familiarity with FDA and international quality regulations, including:
• 21 CFR Part 820
• 21 CFR Part 803
• 21 CFR Parts 210/211
• ISO 13485
• MDSAP
• CMDCAS
• EU MDR
• Medical Device Directive (MDD)
• Exposure to Quality Management Systems (QMS).

Required Skills

• Strong analytical and problem-solving abilities.
• Excellent organizational and time management skills.
• Ability to manage multiple priorities and meet deadlines.
• Strong written and verbal communication skills.
• Ability to work effectively with both technical and non-technical teams.
• Ability to follow documented procedures and SOPs.
• Ability to read and interpret technical documentation, investigations, and service reports.
• Basic understanding of medical devices, pharmaceuticals, or biologics is a plus.
• Proficiency with Microsoft Office Suite (Excel, Word, PowerPoint).
• Ability to quickly learn new database and quality management systems.