Sr. Complaint Handling Specialist

Diality, Inc.; Irvine (CA); Presencial; USD 110 000 - 150 000; Tempo integral

Resumo da oferta

Diality, Inc. in Irvine, CA, is seeking a Senior Complaint Handling Specialist to lead end-to-end complaint handling in compliance with FDA 21 CFR Part 820, ISO 13485, and EU MDR.

The role requires strong technical judgment and cross-functional collaboration to manage investigations from intake to closure. You will coordinate with Engineering, Quality, and Regulatory Affairs, perform data analysis on complaint trends, support MDR reporting, and ensure documentation quality in the eQMS.

Qualificações

• BA/BS in Life Sciences, Engineering, or similar field.
• 5–7+ years of complaint handling, post-market surveillance, or post-market quality experience within the medical device industry.
• Strong working knowledge of ISO 13485, FDA 21 CFR Part 820, and EU MDR regulations.

Responsabilidades

• Coordinate end-to-end complaint handling, including intake, investigation, and closure.
• Ensure records are complete and accurate in the eQMS.
• Evaluate severity, patient impact, and escalation criteria.
• Coordinate investigations with cross-functional teams.
• Ensure compliant documentation of investigation outcomes and conclusions.
• Support MDR/Vigilance reporting activities with Regulatory Affairs.
• Perform complaint trending and data analysis to identify recurring issues.

Conhecimentos

Root cause analysis

Complaint investigation

Documentation quality

Cross-functional collaboration

Data analysis

Regulatory knowledge

Written communication

Oral communication

MS Office

QMS software

Formação académica

BA/BS Degree in Life Sciences or Engineering

Ferramentas

eQMS software

MS Word

MS Excel

Descrição da oferta de emprego

Description

Company & Job Overview

Diality is a medical device company focused on developing solutions to improve lives impacted by kidney disease. Diality offers the Moda-flx Hemodialysis System, a user-friendly, mobile, and connected hemodialysis system designed to maximize clinical flexibility and ease-of-use for both clinical and non-clinical users. The Moda-flx Hemodialysis system combines flow rate capabilities of conventional in-center dialysis devices with a fully integrated reverse osmosis (RO) water filtration system to provide a broad range of prescriptions and meet the needs of any professional dialysis care setting.

The Senior Complaint Handling Specialist is responsible for the hands-on execution and coordination of end-to-end complaint handling activities in compliance with FDA 21 CFR Part 820, ISO 13485, and applicable global regulatory requirements. This role serves as a key contributor within the Quality function, ensuring timely, accurate, and compliant intake, investigation, documentation, and closure of product complaints.

This position requires strong technical judgment, cross-functional collaboration, and the ability to independently manage complex complaint investigations while supporting complaint trending, CAPA inputs, and inspection readiness.

Responsibilities

• Coordinate and execute end-to-end complaint handling activities, including intake, triage, investigation, root cause evaluation, and closure in accordance with internal procedures and regulatory requirements.
• Ensure complaint records are complete, accurate, and timely within the electronic Quality Management System (eQMS).
• Evaluate complaints for severity, potential patient impact, and escalation criteria.
• Coordinate investigations with Engineering, Quality, and Medical Affairs as needed.
• Ensure consistent and compliant documentation of investigation outcomes and conclusions.
• Assess complaints for potential reportability and support MDR/Vigilance reporting activities in collaboration with Regulatory Affairs.
• Perform complaint trending and data analysis to identify recurring issues or emerging quality signals.

Required Skills & Abilities

• Strong investigation and root cause analysis skills
• High attention to detail and documentation quality
• Ability to independently manage multiple complaint investigations
• Clear and professional written and verbal communication
• Effective cross-functional collaboration skills
• Data-driven mindset with expertise analyzing complaint trends
• Good knowledge of Clinical evaluation and investigation of medical devices.
• Excellent interpersonal skills including ability to interact with high degree of diplomacy.
• Excellent problem-solving skills, applied thinking skills and technical writing skills.
• Excellent communication and organization skills required.
• Ability to work in a fast-paced, technically challenging environment where drive is critical to success.
• Expertise in Microsoft Office applications, such as MS Word and Excel.
• Proficiency with electronic software systems used in QMS

Education & Experience

• A minimum BA/BS Degree in Life Sciences, Engineering, or similar field
• 5–7+ years of complaint handling, post-market surveillance, or post-market quality experience within the medical device industry.
• Strong working knowledge of ISO 13485, FDA 21 CFR Part 820, and EU MDR regulations. Familiarity with life-support or high-risk medical devices
• Experience supporting audits or regulatory inspections

  Travel

  • Ability to travel as required

  Physical Requirements

  • Prolonged periods of sitting at a desk and working on a computer
  • May be expected to lift 15 pounds at times

  Working Environment:

  • Office or work-station environment

  The information contained in this job description is for compliance with the Americans with Disabilities Act (ADA) and is not an exhaustive list of duties performed for this position.