Customer Quality & Complaint Specialist

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.

Duties & 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.