Complaints Specialist - Medical Device #9552

ECI; Carlsbad (CA); On-site; USD 80,000 - 110,000; Full time

Job summary

ECI is seeking a dedicated Complaints Specialist to investigate and document customer complaints about medical device performance, ensuring compliance with FDA 21 CFR 820, ISO 13485, and MDR. You will analyze failure trends, perform risk assessments, and manage regulatory reporting to safeguard post-market safety.

You’ll lead root cause investigations, interact with customers, and collaborate with engineering and quality teams to close out investigations in a timely, compliant manner.

Qualifications

• Bachelor’s degree in engineering, biomedical engineering, or scientific field, or equivalent industry experience.
• 2-4 years of experience in complaint handling, quality assurance, or regulatory affairs within the medical device industry.
• Strong knowledge of FDA 21 CFR Part 820, 21 CFR Part 803 (MDR), and ISO 13485.
• Experience with QMS software and databases, plus the ability to read technical documents.
• Professional verbal and written communication skills to interact with clinicians and users.
• Excellent documentation skills for creating detailed investigation reports.
• Strong ability to analyze complex data to identify patterns.

Responsibilities

• Receive, log, and evaluate customer complaints to determine if they meet the criteria for potential investigation.
• Investigate complaints, including reviewing device history records (DHR) and conducting failure analyses of returned devices to determine root causes.
• Review and file mandatory Medical Device Reports (MDRs) and adverse event reports to regulatory agencies within required timelines,
• Ensure all complaint records are accurate, complete, and closed in compliance with quality systems and procedures.
• Trend analysis on complaint data, identifying emerging safety issues and initiating corrective and preventive actions (CAPA).

Skills

Complaint handling

Quality assurance

Regulatory affairs

FDA regulations

MDR knowledge

ISO 13485

QMS software

Reading technical docs

Verbal communication

Written communication

Data analysis

Education

Bachelor's degree in engineering/biomedical or similar

Tools

QMS software

Job description

About ECI

ECI’s mission is to be the global leader of professional consulting services for the life sciences industry. Our clients lean on our diverse perspectives and decades of expertise to tackle their toughest challenges, and we take pride in providing them transformative solutions with distinctive, sustainable and long-term value. ECI boasts a proven track record of providing full product life cycle consulting on a variety of challenging and exciting projects. Our collaborative culture, welcoming team and flexible employment & benefit options allow us to maintain strong relationships with the most talented individuals in the life sciences industry.

Brief Description

About ECI

ECI’s mission is to be the global leader of professional consulting services for the life sciences industry. Our clients lean on our diverse perspectives and decades of expertise to tackle their toughest challenges, and we take pride in providing them transformative solutions with distinctive, sustainable and long-term value. ECI boasts a proven track record of providing full product life cycle consulting on a variety of challenging and exciting projects. Our collaborative culture, welcoming team and flexible employment & benefit options allow us to maintain strong relationships with the most talented individuals in the life sciences industry.

About The Role

The Complaints Specialist will be responsible for investigating, documenting and closing out customer complaints regarding medical device performance, ensuring compliance with FDA 21 CFR 820, ISO 13485, and MDR regulations. The ideal candidate will bring strong ability to analyze failure trends, perform risk assessments, and manage regulatory reporting to ensure post-market safety. Key duties involve root cause investigation, interacting with customers, and collaborating with engineering/quality teams.

What You’ll Do

• Receive, log, and evaluate customer complaints to determine if they meet the criteria for potential investigation.
• Investigate complaints, including reviewing device history records (DHR) and conducting failure analyses of returned devices to determine root causes.
• Review and file mandatory Medical Device Reports (MDRs) and adverse event reports to regulatory agencies within required timelines,
• Ensure all complaint records are accurate, complete, and closed in compliance with quality systems and procedures.
• Trend analysis on complaint data, identifying emerging safety issues and initiating corrective and preventive actions (CAPA).

What We Look For

• Bachelor’s degree in engineering, biomedical engineering, or scientific field, or equivalent industry experience.
• 2-4 years of experience in complaint handling, quality assurance, or regulatory affairs within the medical device industry.
• Strong knowledge of FDA 21 CFR Part 820, 21 CFR Part 803 (MDR), and ISO 13485.
• Experience with QMS software and databases, plus the ability to read technical documents.
• Professional verbal and written communication skills to interact with clinicians and users.
• Excellent documentation skills for creating detailed investigation reports.
• Strong ability to analyze complex data to identify patterns.