Post-Market Surveillance Analyst

At Q’Apel, we are passionate about revolutionizing neurovascular access. In the simplest sense, we’re a company that creates solutions. We design novel access device technology for vascular interventions and unmet clinical needs. Because in the precious seconds that surround a stroke emergency, clinicians need technology that delivers. That’s where Q’Apel comes in.

Successful Q’Apel team members step up to the plate and work together to achieve our goals every single day. We are a fast-paced, high-growth company with a startup philosophy that requires an all-hands-on-deck attitude, taking on all changes with excitement and a great attitude.

Post-Market Surveillance Analyst

4245 Technology Drive, Fremont, CA 94538 (Onsite)

Full-Time/Exempt

As a Post-Market Surveillance Analyst, you will support Q’Apel’s complaint handling and post-market surveillance program from two directions at once: the administrative processing of complaints and MDR-reportable events, and the hands‑on engineering analysis of returned devices. You will help the team keep pace with a growing volume of complaint and MDR case activity — driven by increased Zebra complaint volume and the upcoming Lynx launch — while supporting tracking and trending, Emerging Trends meetings, and clinical documentation data needs.

As a Post-Market Surveillance Analyst, you will support Q’Apel’s complaint handling and post-market surveillance program from two directions at once: the administrative processing of complaints and MDR-reportable events, and the hands‑on engineering analysis of returned devices. You will help the team keep pace with a growing volume of complaint and MDR case activity — driven by increased Zebra complaint volume and the upcoming Lynx launch — while supporting tracking and trending, Emerging Trends meetings, and clinical documentation data needs.

• Process incoming complaints, including intake, documentation, and case file management in the eQMS.
• Prepare and manage MDR-reportable event case documentation and timelines, ensuring on‑time regulatory filing.
• Support complaint aging management and help maintain on‑time closure targets across the growing case volume.
• Coordinate with Regulatory, Clinical, and R&D on case‑specific follow‑up needs.

• Receive, inspect, and perform failure analysis on returned devices (e.g., fracture, separation, kink, and other integrity‑related complaints).
• Distinguish between device‑related, use‑related, and shipping/handling‑related root causes using physical evidence (visual inspection, dimensional checks, photos/video) and case history.
• Draft clear, well‑supported technical write‑ups of findings to support MDR narratives and CAPA investigations.
• Coordinate with R&D and Manufacturing on design‑or‑process‑related trend findings identified through returned device analysis.
• Compile and maintain complaint and MDR tracking & trending data; prepare materials for and participate in Emerging Trends meetings.
• Support continuous improvement of the post‑market surveillance process, including aging/dashboard tooling and eQMS‑related process updates.
• Support company goals and objectives, policies and procedures; ensure compliance with Quality System Regulations and ISO 13485:2016 requirements.
• Perform other duties as assigned.

This role involves direct physical handling of devices returned from clinical use, which may carry biohazard exposure risk.

• Returned devices submitted for inspection or failure analysis may have been in contact with patient blood, tissue, or other bodily fluids and must be treated as a biohazard until formally…