Customer Quality & Complaint Specialist

Top Quality Recruitment (TQR); Monroe (NJ); On-site; USD 65,000 - 95,000; Full time

Job summary

Top Quality Recruitment (TQR) is seeking a Customer Quality & Complaint Specialist to manage quality concerns, investigate product complaints, coordinate CAPA, and ensure timely resolution to satisfy customers.

You will collaborate with Quality Assurance, Regulatory Affairs, Manufacturing, Engineering, and R&D; maintain records, monitor KPIs, and contribute to FDA/ISO compliance while driving improvements in the customer experience.

Qualifications

• Bachelor’s degree in a related field.
• 3–5 years of experience in customer service or a regulated industry (healthcare preferred).
• Experience handling inquiries, issue resolution, and stakeholder communication.
• Experience coordinating with external service providers or customer service vendors.

Responsibilities

• Manage day-to-day customer service activities, including inquiries, support, issue resolution, and follow-up.
• Coordinate activities with third-party customer service vendors and outsourced call centres.
• Maintain customer service procedures and monitor vendor SLAs.
• Ensure inquiries are handled accurately and within response timelines.
• Maintain complete records of customer communications and service activities.
• Track customer service performance metrics and prepare reports for management.
• Identify opportunities to improve customer service processes and customer experience.
• Support complaint handling in accordance with procedures and regulatory requirements.
• Coordinate investigations with QA, Regulatory Affairs, Manufacturing, Engineering, R&D and cross-functional teams.
• Escalate complaints for CAPA/Risk Management or MDR review as needed.
• Assist with complaint trend analysis and post-market quality activities.

Skills

Medical device complaint handling

FDA QSR/ISO 13485 familiarity

CRM experience

Education

Bachelor’s degree in Business Administration, Life Sciences, Healthcare, Engineering, Quality, or related field

Tools

CRM software

QMS software

Job description

The Customer Quality & Complaint Specialist will be responsible for managing customer quality concerns, investigating product complaints, coordinating corrective and preventive actions (CAPA), and ensuring customer satisfaction through timely resolution of quality-related issues.

Key Activities

• Manage day-to-day customer service activities, including product inquiries, customer support, issue resolution, and follow-up.
• Coordinate activities with third-party customer service vendors, including ARS and outsourced call centre providers.
• Maintain customer service procedures and monitor vendor service level agreements (SLAs).
• Ensure customer inquiries are handled accurately, professionally, and within established response timelines.
• Maintain complete and accurate records of customer communications and service activities.
• Track customer service performance metrics and prepare periodic reports for management.
• Identify opportunities to improve customer service processes and overall customer experience.
• Receive, review, document, and process customer complaints in accordance with Company procedures and applicable regulatory requirements.
• Evaluate customer feedback to determine whether it meets the definition of a product complaint.
• Coordinate complaint investigations with Quality Assurance, Regulatory Affairs, Manufacturing, Engineering, R&D, and other cross-functional teams.
• Maintain complete and accurate complaint records and ensure timely processing and closure.
• Escalate complaints requiring further Quality review, including CAPA, Risk Management, or MDR evaluation, as appropriate.
• Support complaint trend analysis to identify recurring quality issues and opportunities for improvement.
• Maintain complaint files and related documentation in accordance with document control procedures.
• Manage day-to-day communication with outsourced customer service vendors and call centre providers.
• Monitor vendor performance using established KPIs and service level agreements.
• Conduct periodic vendor performance reviews and follow up on corrective or improvement actions.
• Ensure vendors follow approved customer service and complaint handling procedures.
• Coordinate training and communications with vendor personnel regarding customer service and complaint handling processes.
• Support preparation of complaint-related documentation for FDA inspections, ISO 13485 audits, internal and customer audits.
• Support complaint trending, data analysis, and post-market quality activities. Participate in CAPA activities and Management Review by preparing complaint and customer service performance data.

Preferred Skills

• Experience with medical device complaint handling, customer quality, or Quality Management System (QMS) processes.
• Familiarity with FDA Quality System requirements, ISO 13485, CAPA, or post-market surveillance.
• Experience using CRM, complaint management, or QMS software.

Educations & Experience

• Bachelor’s degree in Business Administration, Life Sciences, Healthcare, Engineering, Quality, or a related field.
• 3–5 years of experience in customer service, customer support, or customer relationship management, preferably in a healthcare or other regulated industry.
• Experience handling customer inquiries, issue resolution, and communication with internal and external stakeholders.
• Experience coordinating with external service providers or customer service vendors.

Finding a great opportunity that fosters growth, a great culture, and leadership opportunities can be difficult. Top Quality Recruitment (TQR) connects professionals with leadership opportunities across the Packaging, Food and Beverage, Medical Devices, and Biotechnology industries. With 50+ years of experience, we believe in one-to-one communication and finding the best candidate/employer match possible.

TQR is an equal-opportunity employer that encourages diversity. We will consider all applications.

Accommodation for applicants with disabilities is available upon request.

We thank all applicants for their interest and appreciate the time and effort involved; however, due to the large volume of resumes received only those candidates selected for an interview will be contacted.