Post-Market Surveillance Analyst at Q'Apel Medical in FREMONT, CA

Job description

• 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.

Responsibilities

• 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 data requests for clinical documentation deliverables (CERs, PSURs, PMCF reports).
• 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.

Requirements

• What You Bring:
• Bachelor’s degree in an engineering, life science, or related technical discipline required. Applicable work experience may be substituted for education experience.
• Minimum 3–6 years of experience in complaint handling, post-market surveillance, or quality engineering within the medical device industry.
• Working knowledge of MDR reporting requirements and complaint handling regulations (21 CFR 803/820, ISO 13485:2016).
• Demonstrated experience performing failure analysis or root-cause investigation on returned/failed hardware; catheter or other minimally invasive device experience strongly preferred.
• Strong technical writing skills, with the ability to produce clear, well-supported findings for regulatory and CAPA documentation.
• Comfortable managing a steady caseload across both administrative and hands-on technical work without either falling behind.
• Experience with tracking & trending, data compilation, or supporting clinical documentation data requests a plus.
• Detail-oriented, organized, and able to manage multiple cases and deadlines simultaneously.

Skills

Required

• Complaint handling
• Post-market surveillance
• Quality engineering
• MDR reporting requirements
• Failure analysis
• Root-cause investigation
• Technical writing
• Case management
• Tracking & trending
• Data compilation
• Detail-oriented
• Organized

Benefits

• The anticipated salary range for candidates who will work in Fremont, California is $130,000 to $145,000. Our salary ranges are calculated by role and level. Your position within that range will be determined by your job-related knowledge, skills, experience, relevant education, and training/certifications. In addition to those factors, we also examine internal equity as well as considering the current market rate, and title may be assessed one level lower or higher accordingly.