Senior Medical Device Complaint Investigator

Diality, Inc.; Irvine (CA); On-site; USD 110,000 - 150,000; Full time

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Root cause analysis

Complaint investigation

Documentation quality

Cross-functional collaboration

Data analysis

Regulatory knowledge

Written communication

Oral communication

MS Office

QMS software

Education

BA/BS Degree in Life Sciences or Engineering

Tools

eQMS software

MS Word

MS Excel

Job description

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.