Quality Complaint Analyst

The role

This person will manage the complaint handling process from intake through investigation and closure. They will work with cross-functional partners to ensure accurate documentation and regulatory reportability.

What you will do

• Execute and maintain the complaint handling process.
• Manage product complaints throughout their full lifecycle.
• Collaborate with Customer Support, Engineering, Service, and Medical/Clinical advisors.
• Contribute continuous improvements to the Complaint Handling process.
• Provide information for timely Adverse Event reporting.
• Facilitate complaint progress to ensure proper documentation and timely closure.
• Perform reportability determinations with a medical advisor.
• Complete investigations of reportable and non-reportable product complaints.
• Comply with FDA regulations, regulatory requirements, and company policies.
• Support additional Quality Systems activities and assigned tasks.

Required qualifications

• Bachelor's degree in Biomedical Engineering, Industrial Engineering, Biotechnology, or related field.
• Minimum of 2 years of relevant experience in the medical device industry.
• Working knowledge of FDA Quality Management System Regulation (QMSR), ISO 13485, and applicable U.S. medical device regulatory requirements.
• Familiarity with FDA Medical Device Reporting requirements (21 CFR Part 803) and medical device complaint handling processes.
• Understanding of Good Manufacturing Practices (GMP), quality management systems, and documentation practices.
• Familiarity with complaint investigations, root cause analysis, and Corrective and Preventive Actions (CAPA).
• Strong analytical, problem-solving, and attention-to-detail skills.
• Ability to manage multiple priorities and work effectively in a fast-paced, cross-functional environment.
• Proficiency in Microsoft Office.
• Fluency in English, both written and verbal.

Nice to have

• Experience in Quality Assurance, Complaint Handling, or Post-Market Surveillance.
• Experience with electronic Quality Management Systems (eQMS).
• Excellent interpersonal skills.
• A self-starter, motivated and able to positively motivate others.

About the company

Outset Medical is a medical device company revolutionizing the field of dialysis with the Tablo Hemodialysis System. The company focuses on creating technology to reduce the cost and complexity of dialysis.