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DHD Consulting

Customer Quality & Complaint Specialist

Job ID: 645897

Role details

  • Job Purpose
  • - Serve as the primary point of contact for day-to-day customer service activities, ensuring timely and professional support for customers.
  • - Coordinate customer inquiries, customer service vendors, and complaint
  • handling activities while supporting compliance with applicable regulatory

Requirements

  • and the Company's Quality Management System (QMS).
  • - Collaborate with cross-functional teams to improve customer satisfaction,
  • complaint resolution, and post-market quality processes.

Responsibilities

  • & Responsibilities
  • Customer Service Operations
  • - 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 center 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
  • Complaint Handling & Customer Quality
  • - 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.
  • Vendor Management
  • - Manage day-to-day communication with outsourced customer service vendors and call center 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.
  • Regulatory & Quality Support
  • - 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.
  • - Maintain complaint handling SOPs, work instructions, and related training
  • records.
  • - Identify opportunities to improve customer quality processes and regulatory
  • compliance.
  • Qualification
  • Education
  • - Bachelor’s degree in Business Administration, Life Sciences, Healthcare,
  • Engineering, Quality, or a related field.
  • Experience
  • [Required]
  • - 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.
  • [Preferred]
  • - 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.
  • Knowledge & Skills
  • [Required]
  • - Excellent customer service, communication, and interpersonal skills.
  • - Strong organizational, analytical, and problem-solving skills with attention to detail.
  • - Ability to manage multiple priorities and work effectively in a cross-functional environment.
  • - Proficiency in Microsoft Office.
  • [Preferred]
  • - Basic knowledge of medical device complaint handling and applicable FDA
  • Quality System requirements and ISO 13485.
  • - Familiarity with CAPA, document control, or electronic QMS/CRM systems.