Post‑Market Surveillance Analyst: MDR & Failure Analysis

Q'Apel Medical, Inc; Fremont (CA); On-site; USD 130,000 - 145,000; Full time

Job summary

Q’Apel Medical, Inc in Fremont, CA, is seeking a Post-Market Surveillance Analyst to support complaint handling and MDR reporting, plus hands-on engineering analysis of returned devices. You will manage case documentation, perform failure analysis, draft technical write-ups, and help drive trending meetings and CAPA investigations in a regulated QA environment.

This onsite role requires a Bachelor’s in engineering or life sciences and 3–6 years of medical device quality experience; located in

Qualifications

• Bachelor’s degree in an engineering, life science, or related technical discipline.
• 3–6 years of experience in complaint handling or post-market surveillance in medical devices.
• Experience with MDR reporting requirements (21 CFR 803/820) and ISO 13485:2016.
• Strong technical writing and ability to produce regulatory documentation.

Responsibilities

• Process and manage complaints and MDR events in the eQMS.
• Conduct failure analysis of returned devices and determine root causes.
• Prepare technical write-ups for MDR narratives and CAPA.
• Coordinate with R&D and Manufacturing on trends and improvements.
• Maintain complaint tracking, trending data, and Emerging Trends materials.
• Ensure compliance with QMS and ISO 13485:2016 requirements.

Skills

Post-market surveillance

MDR reporting

Complaint handling

Quality engineering

Technical writing

Root cause analysis

Data tracking

Laboratory inspection

Education

Bachelor's degree in Engineering/Life Science

Job description

Q’Apel Medical, Inc in Fremont, CA, is seeking a Post-Market Surveillance Analyst to support complaint handling and MDR reporting, plus hands-on engineering analysis of returned devices. You will manage case documentation, perform failure analysis, draft technical write-ups, and help drive trending meetings and CAPA investigations in a regulated QA environment.

This onsite role requires a Bachelor’s in engineering or life sciences and 3–6 years of medical device quality experience; located in