Post Market Complaint Specialist

El Camino Health; Manila; On-site; PHP 600,000 - 800,000; Full time

Job summary

El Camino Health is seeking a Complaint Handling Specialist in Manila. This role involves the intake, evaluation, and resolution of product complaints while ensuring compliance with internal procedures and relevant regulations. The ideal candidate will engage with cross-functional teams to enhance product quality and patient safety.

The responsibilities include documenting complaints in the electronic Quality Management System and conducting thorough investigations to determine root causes. Candidates with a background in regulatory compliance and strong analytical skills are encouraged to apply.

Qualifications

• Experience in complaint handling or similar roles is preferred.
• Strong analytical skills for root-cause analysis.
• Understanding of regulatory compliance, such as ISO13485 and 21CFR.

Responsibilities

• Receive, log, and acknowledge customer complaints within established timelines.
• Conduct detailed investigations, including root-cause determination.
• Ensure complaint records are properly documented in the eQMS.

Job description

About This Role

The Complaint Handling Specialist is responsible for the intake, evaluation, investigation, documentation, and closure of product complaints in compliance with internal procedures and regulatory requirements. This role ensures timely and accurate processing of complaints, supports root‑cause analysis, and collaborates with cross‑functional teams to drive corrective and preventive actions that enhance product quality and patient safety.

Key Responsibilities

• Receive, log, and acknowledge customer complaints within established timelines.
• Review complaint information for completeness, accuracy, and classification (e.g., reportable vs. non‑reportable).
• Conduct detailed investigations, including root‑cause determination, in coordination with Quality Engineering, Manufacturing, and R&D teams.
• Ensure complaint records are properly documented in the electronic Quality Management System (eQMS).
• Maintain compliance with complaint handling procedures per ISO13485, 21CFR820.198, and EU MDR.

Location: Manila

Equal Opportunity & Accommodations

iRhythm Technologies, Inc. is an Equal Opportunity Employer. We will consider for employment all qualified applicants with arrest and conviction records in accordance with all applicable laws. iRhythm provides reasonable accommodations for qualified individuals with disabilities in job application procedures, including those who may have any difficulty using our online system. If you need such an accommodation, you may contact us at [e-mail].